FDA Product Code
FDA Product Code KKX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4370
510(k) Clearances — 450 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000417 | CONVERTORS EQUIPMENT DRAPES | Allegiance Healthcare Corp. | 2000-03-17 | Traditional | PDF ↗ |
| K994211 | ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 | Dentsply Intl. | 2000-02-04 | Traditional | PDF ↗ |
| K993795 | CONVERTORS SURGICAL DRAPES | Allegiance Healthcare Corp. | 2000-01-12 | Traditional | PDF ↗ |
| K991667 | BROADLINE OR TOWELS | Broadline Medical Industries | 1999-09-27 | Traditional | PDF ↗ |
| K990253 | SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 | Amba Medical , Ltd. | 1999-09-24 | Traditional | PDF ↗ |
| K991548 | HAL SCOPE HOLDER SYSTEM | Noved Medical | 1999-06-23 | Traditional | PDF ↗ |
| K981823 | OPERATING ROOM TOWELS | Baldur Systems Corp. | 1998-08-11 | Traditional | PDF ↗ |
| K981818 | CONVERTORS TRILAMINATE DRAPES | Allegiance Healthcare Corp. | 1998-07-10 | Traditional | PDF ↗ |
| K980210 | VARIOUS SURGICAL OR PATIENT DRAPES | Gel-Lite, LLC | 1998-05-15 | Traditional | PDF ↗ |
| K974672 | MSI SURGICAL DRAPES | Medical Specialty Innovations, Inc. (Msi) | 1998-03-13 | Traditional | PDF ↗ |
| K980183 | PROMAX SURGICAL DRAPES AND COVERS | Standard Textile Co., Inc. | 1998-02-26 | Traditional | PDF ↗ |
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | Customed, Inc. | 1998-01-05 | Traditional | PDF ↗ |
| K973146 | MENTOR SUPER ABSORBENT DRAPE | Mentor Ophthalmics, Inc. | 1997-12-04 | Traditional | PDF ↗ |
| K970889 | ULTRASOUND TRANSDUCER DRAPE | Protek Medical Products, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K971089 | OPPORTUNITY, INC. LACERATION TRAY | Opportunity, Inc. | 1997-09-16 | Traditional | PDF ↗ |
| K972187 | BOUFFANT CAP | American Seal Co. | 1997-09-09 | Traditional | PDF ↗ |
| K970891 | DRAPE, SURGICAL-LATEX | Protek Medical Products, Inc. | 1997-08-22 | Traditional | PDF ↗ |
| K971159 | SURGICAL DRAPES | International Medsurg Connection | 1997-06-24 | Traditional | PDF ↗ |
| K970554 | CONVERTORS SMS DRAPES | Allegiance Healthcare Corp. | 1997-05-27 | Traditional | PDF ↗ |
| K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER | Contour Fabricators, Inc. | 1997-04-10 | Traditional | PDF ↗ |
| K970722 | EYE TRAY | Trinity Laboratories, Inc. | 1997-03-31 | Traditional | PDF ↗ |
| K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | Medline Industries, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K963675 | THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE | Micro-Medical Devices, Inc. | 1997-01-27 | Traditional | PDF ↗ |
| K964125 | CONVERTORS DRAPE MATERIAL | Allegiance Healthcare Corp. | 1996-12-23 | Traditional | PDF ↗ |
| K962205 | STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE | Medline Industries, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K955749 | TEX-CARE STERILE STOCKINETTE | Flynt Amtex, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K962003 | TUAT SPLATTER CONTROL SHIELD SCS-300 | Taut, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K960803 | RX TEXTILES STERILE STOCKINETTE | Rx Textiles, Inc. | 1996-07-12 | Traditional | PDF ↗ |
| K960045 | ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE | The Sewing Source, Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K954824 | PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE | Medical Creative Technologies, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K960242 | CPR EYE TRAY | Custom Pack Reliability | 1996-03-12 | Traditional | PDF ↗ |
| K955872 | VOLMED OPERATION DRAPE | Medal Intl. Sales Co., LLC | 1996-03-12 | Traditional | PDF ↗ |
| K950565 | DEROYAL SURGICAL INSTRUMENT DRAPE | Deroyal Industries, Inc. | 1995-12-13 | Traditional | PDF ↗ |
| K954212 | CONTAMINATION CONTAINMENT DRAPE | Engineering Controls For Medicine | 1995-10-23 | Traditional | PDF ↗ |
| K952759 | TOWEL PACK | Medcare Custom Packaging, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K953654 | ORS-111 | O.R. Solutions, Inc. | 1995-09-22 | Traditional | PDF ↗ |
| K933148 | SURGICAL DRAPE KIT | Nobelpharma USA, Inc. | 1995-06-26 | Traditional | PDF ↗ |
| K945755 | OREX(R) O.R EQUIPMENT DRAPES | Thantex Specialties, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K951214 | STERILE EQUIPMENT COVER | Gulfstream Medical | 1995-05-16 | Traditional | PDF ↗ |
| K950830 | STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP | Avail-Southwest Division | 1995-05-03 | Traditional | PDF ↗ |
| K941802 | OR TOWEL | Hermitage Hospital Products, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K946060 | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 | Remington Medical, Inc. | 1995-04-27 | Traditional | PDF ↗ |
| K945656 | THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE | Micro-Medical Devices, Inc. | 1995-03-28 | Traditional | PDF ↗ |
| K944863 | COMPEL SURGICALDRAPES | Standard Textile Co., Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K944859 | OREX SURGICAL DRAPES | Thantex Specialties, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K945486 | SPLATTER CONTROL SHIELD | Taut, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K946024 | 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS | 3M Healthcare | 1995-02-08 | Traditional | PDF ↗ |
| K943393 | CIVCO PROBE BOOT/CORD COVER | CIVCO Medical Instruments Co., Inc. | 1995-02-02 | Traditional | PDF ↗ |
| K946025 | 3M X-LARGE SHEET #7979/ #7979NS | 3M Healthcare | 1995-02-02 | Traditional | PDF ↗ |
| K942294 | ASEP PLUS SURGICAL DRAPES | Angelica Uniform | 1995-01-02 | Traditional | PDF ↗ |
| K942228 | OREX O.R. TOWEL | Thantex Specialties, Inc. | 1994-12-20 | Traditional | PDF ↗ |
| K931267 | CONVERTORS ISO BAC DRAPE MATERIAL | Baxter Healthcare Corp | 1994-11-07 | Traditional | PDF ↗ |
| K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE | Hydro-Med Products, Inc. | 1994-10-28 | Traditional | PDF ↗ |
| K923960 | UPPER EXTERMITY DRAPE KIT | Medikmark, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K931143 | AMSCO STERILE RECOVERIES ABSORBENT TOWELS | Amsco Sterile Recoveries, Inc. | 1994-09-08 | Traditional | PDF ↗ |
| K943122 | SURGICAL DRAPES | Mallinckrodt Group, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K941233 | GLOBAL SHOULDER O.R. DRAPE PACK | Depuy, Inc. | 1994-07-27 | Traditional | PDF ↗ |
| K931146 | SURGICAL DRAPES, MODIFICATION | Amsco Sterile Recoveries, Inc. | 1994-06-13 | Traditional | PDF ↗ |
| K940175 | MEDSURG STERILE O.R. TOWELS | Medsurg Industries, Inc. | 1994-05-26 | Traditional | PDF ↗ |
| K941302 | STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE | Cush Industries, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K931455 | HEAD SHEET | Custom Medical Products, Ltd. | 1994-05-05 | Traditional | PDF ↗ |
| K930815 | ABDOMINAL / THORACIC PATIENT DRAPE | Custom Medical Products, Ltd. | 1994-05-05 | Traditional | PDF ↗ |
| K931418 | SURGICAL DRAPE | Custom Medical Products, Ltd. | 1994-05-05 | Traditional | PDF ↗ |
| K940702 | CONVERTORS OPTI-SORB DRAPE MATERIAL | Baxter Healthcare Corp | 1994-04-26 | Traditional | PDF ↗ |
| K924101 | STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE | Baxter Healthcare Corp | 1994-04-11 | Traditional | PDF ↗ |
| K934445 | STSTORZ DP5300 AND DP9502 STERILE DRAPES | Storz Instrument Co. | 1994-04-11 | Traditional | PDF ↗ |
| K934215 | CONTAIN-OR | Dlp, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K932253 | ARTHROBOT BI-FOLD DRAPE | Andronic Devices, Ltd. | 1994-02-03 | Traditional | PDF ↗ |
| K931091 | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 | Alliance Medical, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K936210 | NPAC | National Healthcare Linen Service | 1994-02-03 | Traditional | PDF ↗ |
| K933382 | IMC CABLE/WIRE COVER | Inman Medical Corp. | 1994-01-27 | Traditional | PDF ↗ |
| K932857 | ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC. | Ansley Medical Products, Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K924335 | DRAPES | Pfb Inter-Apparel Corp. | 1993-09-07 | Traditional | PDF ↗ |
| K922918 | BARRIER SAF-TE HYDROGEL DRAPE | Johnson & Johnson International | 1993-07-06 | Traditional | PDF ↗ |
| K922962 | VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE | Cameo, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K922961 | VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS, | Cameo, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K921657 | VASECTOMY DRAPE | Graham Medical Products | 1993-03-18 | Traditional | PDF ↗ |
| K922059 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | Graham Medical Products | 1993-03-03 | Traditional | PDF ↗ |
| K920346 | VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL | Trinity Laboratories, Inc. | 1993-03-03 | Traditional | PDF ↗ |
| K923811 | COMPEL SURGICAL DRAPES | Standard Textile Co., Inc. | 1993-02-23 | Traditional | PDF ↗ |
| K920808 | OB/GYN DRAPE | Preferred Medical Products | 1993-02-19 | Traditional | PDF ↗ |
| K923688 | N-PAC | National Healthcare Linen Service | 1993-01-27 | Traditional | PDF ↗ |
| K923798 | SURGICAL GOWN PACK | Central Georgia Ancillary Health Systems | 1993-01-27 | Traditional | PDF ↗ |
| K923283 | SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT | Savoy Medical Supply Co., Inc. | 1993-01-04 | Traditional | PDF ↗ |
| K920284 | DRAPE UTILITY/SURGICAL STERILE DISPOSABLE | Trinity Laboratories, Inc. | 1992-10-19 | Traditional | PDF ↗ |
| K921049 | SURGICAL DRAPE | Amsco Sterile Recoveries, Inc. | 1992-10-01 | Traditional | PDF ↗ |
| K922828 | ULCER WOUND TRAY | Ulti-Med Intl., Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K920518 | E.R. SUTURE TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-08-17 | Traditional | PDF ↗ |
| K921204 | DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-08-13 | Traditional | PDF ↗ |
| K921203 | INCISSION & DRAINAGE TRAY | Trinity Laboratories, Inc. | 1992-08-13 | Traditional | PDF ↗ |
| K921394 | DRESSING CHANGE TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-08-13 | Traditional | PDF ↗ |
| K921350 | QUALTEX TUBE/CORD ORGANIZER | Deroyal Industries, Inc. | 1992-08-04 | Traditional | PDF ↗ |
| K920045 | DURATECH HOSPITAL TOWEL | Techstyles | 1992-07-02 | Traditional | PDF ↗ |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | American Threshold Industries, Inc. | 1992-06-22 | Traditional | PDF ↗ |
| K920995 | BARRIER DRAPE SHEET WITH SYMETRY FABRIC | Johnson & Johnson Medical, Inc. | 1992-05-31 | Traditional | PDF ↗ |
| K920517 | MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP | Trinity Laboratories, Inc. | 1992-05-11 | Traditional | PDF ↗ |
| K920341 | LACERATION TRAYS | Medikmark, Inc. | 1992-04-23 | Traditional | PDF ↗ |
| K920340 | SUTURE REMOVAL KIT | Medikmark, Inc. | 1992-04-23 | Traditional | PDF ↗ |
| K914761 | KAY-MED SURGICAL DEAPE/DRAP ACCESSORIES | Kayco Medical, Inc. | 1992-04-06 | Traditional | PDF ↗ |
| K920052 | HEALTH PAK TRAY SOX BARRIERS | Healthpak, Inc. | 1992-04-03 | Traditional | PDF ↗ |
Product code KKX · Class II · General, Plastic Surgery. Data: openFDA.