FDA Product Code
FDA Product Code FQH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5475
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253996 | BD Surgiphor Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026-02-25 | Special | PDF ↗ |
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026-02-20 | Traditional | PDF ↗ |
| K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023-06-15 | Traditional | PDF ↗ |
| K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | 2023-05-25 | Traditional | PDF ↗ |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | 2023-05-16 | Traditional | PDF ↗ |
| K221504 | BD Surgiphor Antimicrobial Irrigation System | Bd | 2022-10-14 | Traditional | PDF ↗ |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2022-09-22 | Special | PDF ↗ |
| K210987 | IRRIGO Wound Wash Jet System | Inopro, Inc. | 2022-05-31 | Traditional | PDF ↗ |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022-03-23 | Traditional | PDF ↗ |
| K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021-05-28 | Traditional | PDF ↗ |
| K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020-12-14 | Traditional | PDF ↗ |
| K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020-10-23 | Traditional | PDF ↗ |
| K192349 | Bactisure Wound Lavage | Next Science, LLC | 2020-01-23 | Traditional | PDF ↗ |
| K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016-09-07 | Traditional | PDF ↗ |
| K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | 2015-07-15 | Traditional | PDF ↗ |
| K113312 | HY-CHLO(TM)WOUND SCRUB | Patrin Pharma | 2012-08-21 | Traditional | PDF ↗ |
| K111313 | EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE | Alcavis Hdc, LLC | 2011-12-14 | Traditional | PDF ↗ |
| K110958 | VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH | Smith & Nephew, Inc. | 2011-08-01 | Traditional | PDF ↗ |
| K090848 | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM | Premier Brands of America, Inc. | 2009-06-17 | Traditional | PDF ↗ |
| K082858 | EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER | Alcavis International, Inc. | 2009-05-27 | Traditional | PDF ↗ |
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM | Irrimax Corporation | 2009-02-04 | Traditional | PDF ↗ |
| K072404 | ERBE ERBEJET 2 SYSTEM | Erbe USA, Inc. | 2007-10-31 | Abbreviated | PDF ↗ |
| K060782 | VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE | Smith & Nephew Wound Management | 2006-04-12 | Traditional | PDF ↗ |
| K033590 | ERBE HELIX HYDRO-JET | Erbe USA, Inc. | 2004-01-30 | Traditional | PDF ↗ |
| K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM | Hydrocision, Inc. | 2003-05-09 | Traditional | PDF ↗ |
| K022613 | HELIX HYDRO-JET | Erbe USA, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K012464 | HELIX HYDRO-JET | Andreas Pein Medizintechnik GmbH | 2001-10-10 | Abbreviated | PDF ↗ |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | Hydrocision, Inc. | 2001-06-22 | Special | PDF ↗ |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | Hydrocision, Inc. | 2000-03-31 | Traditional | PDF ↗ |
| K983135 | BLOWER/MISTER | Cardiothoracic Systems, Inc. | 1998-11-13 | Traditional | PDF ↗ |
| K974568 | CHASE ANASTOMOSIS VISUALIZATION DEVICE | Chase Medical, Inc. | 1998-01-06 | Traditional | PDF ↗ |
| K973803 | FLEXVIEW CO2 BLOWER WITH MIST | Ethicon Endo-Surgery, Inc. | 1997-12-16 | Traditional | PDF ↗ |
| K973485 | CLEARVIEW BLOWER/MISTER | Dlp, Inc. | 1997-12-08 | Traditional | PDF ↗ |
| K972551 | ARTISAN PULSE LAVAGE SYSTEM | Howmedica Corp. | 1997-10-29 | Traditional | PDF ↗ |
| K972069 | STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK | Stryker Instruments | 1997-07-29 | Traditional | PDF ↗ |
| K970916 | H.V. PULSE LAVAGE (L31 SERIES) | Global Medical Products, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K951666 | STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS | Stryker Instruments | 1995-09-19 | Traditional | PDF ↗ |
| K942886 | SIMPULSE SOLO SUCTION IRRIGATOR | Davol Inc., Sub. C. R. Bard, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K933742 | TOP GUN | Bio-Medical Devices, Inc. | 1994-04-07 | Traditional | PDF ↗ |
| K926337 | BONE LAVAGE SYSTEM | Innovative Surgical Devices Corp. | 1993-06-11 | Traditional | PDF ↗ |
| K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | Research Medical, Inc. | 1993-01-29 | Traditional | PDF ↗ |
| K913568 | SURGI-SPRAY O.R. IRRIGATION SYSTEM | Phoenix Surgical Products, Inc. | 1991-11-01 | Traditional | PDF ↗ |
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | American Pharmaseal Div. Ahsc | 1987-12-30 | Traditional | PDF ↗ |
| K874504 | MICRO-AIRE PULSE LAVAGE | Micro-Aire Surgical Instruments, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K873466 | EXCEL PULSED IRRIGATION/SUCTION SYSTEM | Stryker Corp. | 1987-11-06 | Traditional | PDF ↗ |
| K854737 | SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG | Orthopaedic Devices , Ltd. | 1986-05-19 | Traditional | PDF ↗ |
| K854543 | PULSE LAVAGE | Tava Surgical Instruments | 1986-01-27 | Traditional | PDF ↗ |
| K830386 | DAVOL SURGICAL SUCTION IRRIGATION INSTR | C.R. Bard, Inc. | 1983-03-29 | Traditional | PDF ↗ |
| K820661 | MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG | Micro-Aire Surgical Instruments, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K813607 | ACKRAD N-DO VAGE TUBE | Ackrad Laboratories | 1982-02-05 | Traditional | PDF ↗ |
| K813475 | XOMED MICRO-IRRIGATOR | Xomed, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K810185 | IRRIGATION SYRINGE | Karoco Intl. | 1982-01-25 | Traditional | PDF ↗ |
| K790811 | EXETER BONE LAUAGE SYSTEM | Howmedica Corp. | 1979-07-30 | Traditional | PDF ↗ |
Product code FQH · Class II · General Hospital. Data: openFDA.