FDA Product Code
FDA Product Code OMP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4780
510(k) Clearances — 215 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016-10-04 | Traditional | PDF ↗ |
| K152163 | RENASYS GO | Smith & Nephew, Inc. | 2016-09-29 | Traditional | PDF ↗ |
| K162129 | RENASYS-G Gauze Dressing Kits with Soft Port | Smith & Nephew, Inc. | 2016-08-31 | Special | PDF ↗ |
| K161570 | Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large | Lc Medical Concepts, Inc. | 2016-08-29 | Traditional | PDF ↗ |
| K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply | Smith & Nephew Medical, Ltd. | 2016-08-04 | Traditional | PDF ↗ |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016-06-20 | Traditional | PDF ↗ |
| K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack | Kci USA, Inc. | 2016-02-29 | Traditional | PDF ↗ |
| K151263 | Venturi Gauze Wound Care Sets with Portal Drain | Talley Group, Ltd. | 2016-02-19 | Traditional | PDF ↗ |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016-01-28 | Traditional | PDF ↗ |
| K152741 | Mepiseal Soft Silicone Sealant | Molnlycke Health Care Us, LLC | 2016-01-22 | Traditional | PDF ↗ |
| K143004 | VENTURI MiNO TG600/14 | Talley Group, Ltd. | 2016-01-05 | Traditional | PDF ↗ |
| K150459 | FloSure Ventilation Patch | Simex Medizintechnik GmbH | 2016-01-05 | Traditional | PDF ↗ |
| K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing | Kci USA, Inc. | 2015-11-06 | Traditional | PDF ↗ |
| K151872 | Avance Y-Connector S | Molnlycke Health Care Us, LLC | 2015-11-02 | Traditional | PDF ↗ |
| K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large | Medela AG | 2015-10-07 | Traditional | PDF ↗ |
| K150124 | Cardinal Health NPWT PRO HC | Cardinalhealth | 2015-09-02 | Traditional | PDF ↗ |
| K141017 | PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2015-08-20 | Traditional | PDF ↗ |
| K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device | Smith & Nephew, Inc. | 2015-07-23 | Traditional | PDF ↗ |
| K151326 | RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device | Smith & Nephew, Inc. | 2015-07-16 | Special | PDF ↗ |
| K143726 | XLR8 PLUS (XLR8+) | Genadyne Biotechnologies, Inc. | 2015-06-19 | Traditional | PDF ↗ |
| K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters | Medela AG | 2015-06-12 | Traditional | PDF ↗ |
| K151240 | extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc | Devon Medical Products | 2015-06-09 | Special | PDF ↗ |
| K142385 | Whisper Pump System | Wound RX Medical, LLC | 2015-05-22 | Traditional | PDF ↗ |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | Genadyne Biotechnologies, Inc. | 2015-04-30 | Traditional | PDF ↗ |
| K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters | Smith & Nephew, Inc. | 2015-04-29 | Traditional | PDF ↗ |
| K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | Cardinalhealth | 2015-04-20 | Traditional | PDF ↗ |
| K141961 | GENADYNE SPIRO FOAM DRESSING KIT | Genadyne Biotechnologies, Inc. | 2015-03-26 | Traditional | PDF ↗ |
| K141847 | AVANCE FOAM DRESSING KITS | Molnlycke Health Care Us, LLC | 2015-03-26 | Traditional | PDF ↗ |
| K142916 | SVED Wound Treatment System | Cardinalhealth | 2015-03-04 | Traditional | PDF ↗ |
| K143301 | NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit | Integrated Healing Technologies | 2015-03-03 | Traditional | PDF ↗ |
| K142956 | NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit | Integrated Healing Technologies | 2015-02-24 | Traditional | PDF ↗ |
| K143362 | extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister | Devon Medical Products | 2015-02-03 | Special | PDF ↗ |
| K133333 | UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT | Blue Ocean Medical Product, LLC | 2014-12-31 | Traditional | PDF ↗ |
| K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Medela AG | 2014-12-19 | Traditional | PDF ↗ |
| K140022 | NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT | Cork Medical Products, LLC | 2014-10-24 | Traditional | PDF ↗ |
| K141437 | XLR8 PLUS (XLR8+) | Genadyne Biotechnologies, Inc. | 2014-09-19 | Special | PDF ↗ |
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit | Devon Medical, Inc. | 2014-09-19 | Traditional | PDF ↗ |
| K141033 | SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV | Argentum Medical, LLC | 2014-09-12 | Traditional | PDF ↗ |
| K132225 | EXTRICARE | Devon Medical, Inc. | 2014-05-15 | Traditional | PDF ↗ |
| K132004 | NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE | Creo Quality, LLC | 2014-05-02 | Traditional | PDF ↗ |
| K133232 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2014-03-24 | Traditional | PDF ↗ |
| K132936 | NOVOPORE DRESSING | Polynovo Biomaterials Pty, Ltd. | 2014-03-04 | Traditional | PDF ↗ |
| K133276 | V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS | Kci USA, Inc. | 2013-11-19 | Special | PDF ↗ |
| K132741 | V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Kci USA, Inc. | 2013-11-15 | Special | PDF ↗ |
| K122490 | KULAVAC | CG Bio Co., Ltd. | 2013-11-13 | Traditional | PDF ↗ |
| K132446 | RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE | Smith & Nephew, Inc. | 2013-10-23 | Special | PDF ↗ |
| K132252 | EXTRICARE 100CC/ 250CC/ 400CC CANISTERS | Devon Medical | 2013-09-27 | Special | PDF ↗ |
| K121817 | VCARE A | IVT Medical, Ltd. | 2013-09-17 | Traditional | PDF ↗ |
| K131464 | EXTRICARE NPWT FOOT DRESSING | Devon Medical, Inc. | 2013-08-13 | Special | PDF ↗ |
| K123507 | KCI NPWT GAUZE DRESSING | Kci USA, Inc. | 2013-04-04 | Traditional | PDF ↗ |
| K113236 | FORYOU NPWT DEVICE | Foryou Medical Electronics Co, Ltd. | 2013-02-12 | Traditional | PDF ↗ |
| K122132 | AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM | Molnlycke Health Care | 2013-01-17 | Traditional | PDF ↗ |
| K123878 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2013-01-15 | Special | PDF ↗ |
| K112853 | VOLTERA POWERED SUCTION PUMP | Suzric Enterprise Co., Ltd. | 2012-11-09 | Traditional | PDF ↗ |
| K121883 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012-10-11 | Traditional | PDF ↗ |
| K120499 | ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012-10-05 | Traditional | PDF ↗ |
| K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Medela AG | 2012-10-01 | Traditional | PDF ↗ |
| K113291 | SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 | Simex Medizintechnik GmbH | 2012-08-30 | Traditional | PDF ↗ |
| K113199 | KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT | Kevo Medical Supplies | 2012-07-30 | Traditional | PDF ↗ |
| K111949 | AC WOUND TREATMENT SYSTEM | Nanovibronix, Inc. | 2012-06-29 | Traditional | PDF ↗ |
| K120033 | ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT | Kci USA, Inc. | 2012-05-31 | Traditional | PDF ↗ |
| K112127 | PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Smith & Nephew, Inc. | 2012-05-16 | Traditional | PDF ↗ |
| K110078 | EXTRICARE | Devon Medical Products, Inc. | 2012-02-10 | Traditional | PDF ↗ |
| K112458 | PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Medica-Rents Co., Ltd. | 2012-01-05 | Special | PDF ↗ |
| K111170 | PICO | Smith & Nephew, Inc. | 2011-12-15 | Traditional | PDF ↗ |
| K111333 | ANTLIA III WOUND TREATMENT SYSTEM | Innovative Therapies, Inc. | 2011-08-08 | Special | PDF ↗ |
| K111280 | V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT | Kci USA, Inc. | 2011-07-21 | Traditional | PDF ↗ |
| K110647 | RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS | Smith & Nephew, Inc. | 2011-06-22 | Traditional | PDF ↗ |
| K103156 | V.A.C. VERAFLO CLEANSE DRESSING SYSTEM | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2011-03-14 | Special | PDF ↗ |
| K100823 | WOUND PRO APEX | Accuro Medical Products, LLC | 2011-01-24 | Traditional | PDF ↗ |
| K102956 | V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010-12-15 | Special | PDF ↗ |
| K100657 | V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010-09-17 | Traditional | PDF ↗ |
| K102001 | MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY | Smith & Nephew, Inc. | 2010-08-06 | Special | PDF ↗ |
| K092992 | A4-XLR8 FOAM DRESSING | Genadyne Biotechnologies, Inc. | 2010-06-29 | Traditional | PDF ↗ |
| K100821 | PREVENA INCISION MANAGEMENT SYSTEM | Kci USA, Inc. | 2010-06-11 | Traditional | PDF ↗ |
| K093526 | V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010-03-10 | Traditional | PDF ↗ |
| K091585 | VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 | Kci USA, Inc. | 2009-12-29 | Traditional | PDF ↗ |
| K093564 | SVED WOUND TREATMENT SYSTEM | Innovative Therapies, Inc. | 2009-11-25 | Special | PDF ↗ |
| K090258 | VENTURI NPWT V. II ADVANCED VACUUM SYSTEM | Talley Medical | 2009-08-25 | Traditional | PDF ↗ |
| K091470 | RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 | Smith & Nephew, Inc. | 2009-07-09 | Traditional | PDF ↗ |
| K090638 | GENADYNE A4-XLR8 WOUND VACUUM SYSTEM | Genadyne Biotechnologies, Inc. | 2009-04-29 | Special | PDF ↗ |
| K090130 | ATMOS S041 WOUND | Atmos, Inc. | 2009-04-02 | Traditional | PDF ↗ |
| K083357 | OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 | Kci USA, Inc. | 2009-03-04 | Traditional | PDF ↗ |
| K083375 | RENASYS GO NEGATIVE PRESSURE WOUND THERAPY | Smith & Nephew, Inc. | 2009-02-25 | Traditional | PDF ↗ |
| K082676 | GENADYNE A4 WOUND VACUUM SYSTEM | Genadyne Biotechnologies, Inc. | 2008-12-18 | Traditional | PDF ↗ |
| K082415 | PRODIGY NPWT SYSTEM MODEL PRODIGY 800V | Premco Medical Systems, Inc. | 2008-11-25 | Traditional | PDF ↗ |
| K082211 | RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS | Smith & Nephew, Inc. | 2008-11-14 | Traditional | PDF ↗ |
| K080275 | NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Iasis Medical, Inc. | 2008-10-09 | Traditional | PDF ↗ |
| K082311 | EXSUDEX WOUND DRAINAGE PUMP | The Medical Company | 2008-10-08 | Abbreviated | PDF ↗ |
| K082426 | RENASYS EZ | Smith & Nephew, Inc. | 2008-09-05 | Special | PDF ↗ |
| K080357 | MEDELA INVIA WOUND THERAPY | Medela AG | 2008-07-24 | Traditional | PDF ↗ |
| K080897 | VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Talley Medical | 2008-07-15 | Traditional | PDF ↗ |
| K063740 | V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 | Kci USA, Inc. | 2007-06-07 | Traditional | PDF ↗ |
| K063692 | V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 | Kci USA, Inc. | 2007-06-07 | Traditional | PDF ↗ |
| K071301 | ANTLIA I WOUND IRRIGATION SYSTEM | Innovative Therapies, Inc. | 2007-05-24 | Traditional | PDF ↗ |
| K070904 | ANTLIA II SUCTION PUMP SYSTEM | Innovative Therapies, Inc. | 2007-04-13 | Traditional | PDF ↗ |
| K061919 | VERSATILE 1 EZCARE WOUND VACUUM SYSTEM | Blue Sky Medical Group Incorporated | 2007-02-05 | Traditional | PDF ↗ |
| K063590 | V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 | Kci USA, Inc. | 2007-01-25 | Special | PDF ↗ |
| K063426 | V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 | Kci USA, Inc. | 2006-12-13 | Special | PDF ↗ |
| K062456 | NOVASPINE POWERED SUCTION PUMP PRO-1 | Novaspine, LLC | 2006-10-16 | Traditional | PDF ↗ |
Product code OMP · Class II · General, Plastic Surgery. Data: openFDA.