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 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K862172 | QUALI-MED'S OPERATING ROOM DRAPES | Quali-Med, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K862062 | NONWOVEN SURGICAL DRAPE PACK | East Texas Lighthouse For the Blind | 1986-06-10 | Traditional | PDF ↗ |
| K861969 | STERILE TOWEL W/ANTIMICROBIAL AGENT | Deroyal Industries, Inc. | 1986-06-04 | Traditional | PDF ↗ |
| K862016 | PACH-PEN SURGICAL DRAPE | Oculab, Inc. | 1986-06-04 | Traditional | PDF ↗ |
| K861531 | DISPOSABLE SURGICAL DRAPES AND ACCESSORIES | Medical Concepts Development, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K861288 | NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES | Procedure Pak, Inc. | 1986-05-06 | Traditional | PDF ↗ |
| K861196 | STERILE STOCKINETTE W/ANTIMICROBIAL AGENT | Deroyal Industries, Inc. | 1986-04-30 | Traditional | PDF ↗ |
| K860936 | ABSORBENT, FIBER, OPERATING ROOM TOWELS | Ulti-Med Intl., Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K850960 | NON-ABSORBENT DRAPES & ABSORBENT TOWELS | Excel Health Care Products | 1986-03-15 | Traditional | PDF ↗ |
| K860326 | TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT | Deroyal Industries, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K860248 | 100% COTTON ABSORBENT TOWEL | Devon Industries, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K860447 | STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400 | Standard Textile Co., Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K853347 | MAI STERILE UTILITY DRAPE | Medical Assoc. Intl., Inc. | 1985-09-05 | Traditional | PDF ↗ |
| K852945 | HUCK TOWEL | South Mountain Medical | 1985-07-29 | Traditional | PDF ↗ |
| K852280 | DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) | Outpatient Products Co. | 1985-07-09 | Traditional | PDF ↗ |
| K850912 | STERILE DISPOSABLE PN DRAPE SYSTEM | Brant-Wald Surgicals, Inc. | 1985-05-03 | Traditional | PDF ↗ |
| K851314 | ABCO DRAPES/TOWELS | Abco Dealers, Inc. | 1985-05-01 | Traditional | PDF ↗ |
| K850326 | STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH | Excel Health Care Products | 1985-02-26 | Traditional | PDF ↗ |
| K850199 | POLY-LINED TOWEL/DRAPE LINE | Excel Health Care Products | 1985-02-21 | Traditional | PDF ↗ |
| K844802 | SURGICAL DRAPES | Procter & Gamble Mfg. Co. | 1985-01-14 | Traditional | PDF ↗ |
| K843724 | I.V. START KIT & OBSTETRICAL KIT | E.M. Adams | 1985-01-10 | Traditional | PDF ↗ |
| K844465 | PMS DRAPE PACK | Professional Medical Services | 1984-12-05 | Traditional | PDF ↗ |
| K844199 | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET | Kleen Test Products | 1984-11-07 | Traditional | PDF ↗ |
| K843496 | DRAPE SURGICAL UTILITY DRAPE STERILE | Busse Hospital Disposables, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K843260 | ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE | Angiosystems, Inc. | 1984-09-21 | Traditional | PDF ↗ |
| K841735 | ACU-DERM TRANSPARENT INCISE DRAPE | Acme United Corp. | 1984-08-02 | Traditional | PDF ↗ |
| K842545 | ALL-HANDS STERILE FIELD-0201 | All-Hands Medical Supply, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K842115 | SPUNGARD & SURG. DRAPES-GOWNS & PACKS | Kimberly-Clark Corp. | 1984-06-11 | Traditional | PDF ↗ |
| K840957 | ANTIMICROBIAL INCISE DRAPE | American Convertors Div., American Pharmaseal | 1984-06-07 | Traditional | PDF ↗ |
| K833176 | SDI SURGICAL DRAPE | Sdi | 1984-04-04 | Traditional | PDF ↗ |
| K833121 | BURLINGTON STERILE ANTIMICROBIAL STOCK | Balfour, Inc. | 1984-01-25 | Traditional | PDF ↗ |
| K833877 | SINGLE-USE SURGICAL DRAPES | Procter & Gamble Mfg. Co. | 1984-01-25 | Traditional | PDF ↗ |
| K833122 | BURLINGTON ANTIMICROBIAL STOCKINEETTE | Balfour, Inc. | 1984-01-25 | Traditional | PDF ↗ |
| K831287 | E-Z FIT | Triad Medical Division | 1983-10-14 | Traditional | PDF ↗ |
| K832278 | LIGHT HANDLE COVER | Concept, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K832874 | ISOVIS WOUND PROTECTOR | Ritmed, Inc. | 1983-09-26 | Traditional | PDF ↗ |
| K830270 | ISOVIS WOUND PROTECTOR | Ritmed, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K830723 | REDI-DRAPE | The Oec Group | 1983-04-12 | Traditional | PDF ↗ |
| K830660 | STERILE SURGICAL DRAPES | Phoenix Glove Co. | 1983-03-17 | Traditional | PDF ↗ |
| K823054 | DRAPE, SURGICAL ANGIOGRAPHY | Triad Medical Division | 1983-01-12 | Traditional | PDF ↗ |
| K822641 | GORE-TEX BARRIER SURG. DRAPES & GOWNS | W. L. Gore & Associates, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K822847 | INSTA-HOLD | Taub Industries | 1982-10-08 | Traditional | PDF ↗ |
| K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE | Surgikos, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K820542 | SURGIKOS INCISE DRAPE | Surgikos, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K820850 | CURITY PREMIUM CYSTOSCOPY TRAY | The Kendal Co. | 1982-05-12 | Traditional | PDF ↗ |
| K820758 | BOUNDARY SINGLE-USE CRANIOTOMY SHEET | The Buckeye Cellulose Corp. | 1982-04-29 | Traditional | PDF ↗ |
| K813360 | DERMAFILE (CAT. # 38 | Exco, Inc. | 1982-03-18 | Traditional | PDF ↗ |
| K813097 | ANAGO STERILE PRODUCTS; STOCKINETTES | Anago, Inc. | 1982-03-10 | Traditional | PDF ↗ |
| K820078 | DRAPE, SURGICAL | James L. Geraci & Associates, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K813450 | BOUNDARY SINGLE-USE DRAPES | The Buckeye Cellulose Corp. | 1982-01-22 | Traditional | PDF ↗ |
| K813551 | SHEETS | Lancaster County Assoc. For the Blind | 1982-01-18 | Traditional | PDF ↗ |
| K813277 | BOUNDARY DRAPE TAPE | The Buckeye Cellulose Corp. | 1981-12-18 | Traditional | PDF ↗ |
| K812962 | BOUNDARY SURGICAL DRAPE | The Buckeye Cellulose Corp. | 1981-11-20 | Traditional | PDF ↗ |
| K812738 | BOUNDARY PROCESS CHANGE | The Buckeye Cellulose Corp. | 1981-11-16 | Traditional | PDF ↗ |
| K812809 | STERILE ADHERENT DRAPES | Abco Dealers, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812448 | UNI-THANE | Unicare Systems, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K801550 | 3M GERMICIDAL SURGICAL INCISE DRAPE | 3M Company | 1981-09-17 | Traditional | PDF ↗ |
| K811871 | BACTERICIDAL INCISE DRAPE | Surgikos, Inc. | 1981-08-20 | Traditional | PDF ↗ |
| K811996 | GATOR DRAPES | The Anspach Effort, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K802790 | SOLVALINE | Secol Co. | 1981-02-13 | Traditional | PDF ↗ |
| K802980 | DISPOSABLE STERILE LAP SPONGE | Anago, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802787 | METALLINE DRESSINGS | Secol Co. | 1980-12-17 | Traditional | PDF ↗ |
| K802797 | O.R. DRAPES | Secol Co. | 1980-12-17 | Traditional | PDF ↗ |
| K802537 | DISPOSABLE SURGICAL DRAPE | Texas Medical Products, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802652 | BOUNDARY SURGICAL DRAPES WITH ADHESIVE | Procter & Gamble Mfg. Co. | 1980-11-12 | Traditional | PDF ↗ |
| K802359 | DISP. FENESTRATED SURG. DRAPE SHEETS | American Convertors Div., American Pharmaseal | 1980-10-31 | Traditional | PDF ↗ |
| K802317 | COMFORT CUSHION DRY BURN PADS, STERILE | American Convertors Div., American Pharmaseal | 1980-10-31 | Traditional | PDF ↗ |
| K802213 | WHITE KNIGHT BOVIE CORD/SUCTION TUBE | G.D. Searle and Co. | 1980-10-10 | Traditional | PDF ↗ |
| K802280 | WHITE KNIGHT DRAPE SEAL | G.D. Searle and Co. | 1980-10-10 | Traditional | PDF ↗ |
| K802192 | BOUNDARY SINGLE-USE DRAPES | Procter & Gamble Mfg. Co. | 1980-09-26 | Traditional | PDF ↗ |
| K802148 | BOUNDARY SINGLE-USE DRAPE | Procter & Gamble Mfg. Co. | 1980-09-26 | Traditional | PDF ↗ |
| K802247 | BOUNDARY SINGLE-USE DRAPES | Procter & Gamble Mfg. Co. | 1980-09-26 | Traditional | PDF ↗ |
| K802001 | LAP SPONGES CAT.#801-850 | Pollak (Intl.), Ltd. | 1980-09-16 | Traditional | PDF ↗ |
| K802050 | TACKMER INCISE DRAPE | American Convertors Div., American Pharmaseal | 1980-09-16 | Traditional | PDF ↗ |
| K801863 | BARRIER TOWEL DRAPE | Surgikos, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K801864 | BARRIER APERTURED DRAPE | Surgikos, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K801068 | STERILE ABDOMINAL PAD | Medspec Corp. | 1980-05-20 | Traditional | PDF ↗ |
| K801032 | STERILE DRAPE 17X18 CODE D-6A | Veratex Corp. | 1980-05-20 | Traditional | PDF ↗ |
| K801132 | BOUNDARY EXTREMITY DRAPE | Procter & Gamble Mfg. Co. | 1980-05-20 | Traditional | PDF ↗ |
| K800928 | WHITE KNIGHT SUPPLEMENTAL DRAPE | G.D. Searle and Co. | 1980-05-20 | Traditional | PDF ↗ |
| K801033 | STERILE DRAPE 17X18 W/3 FENESTRATION | Veratex Corp. | 1980-05-20 | Traditional | PDF ↗ |
| K800817 | SHIELD DISP. REINFORCED DRAPE SHEETS | American Convertors Div., American Pharmaseal | 1980-05-02 | Traditional | PDF ↗ |
| K800278 | MEDSPEC SAFETY PINS | Medspec Corp. | 1980-05-02 | Traditional | PDF ↗ |
| K800552 | ZEISS DISPOSABLE, STERILE SURGICAL DRAPE | Carl Zeiss, Inc. | 1980-03-20 | Traditional | PDF ↗ |
| K800490 | STERILE DRESSING PACK | Medi-Spec | 1980-03-12 | Traditional | PDF ↗ |
| K792623 | STERILIZATION PROCESS/ABSORBENT TOWEL | Procter & Gamble Mfg. Co. | 1980-01-11 | Traditional | PDF ↗ |
| K792621 | STERILIZATION PROCESS CHANGE BOUNDARY | Procter & Gamble Mfg. Co. | 1980-01-11 | Traditional | PDF ↗ |
| K792357 | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN | Alba-Waldensian, Inc. | 1979-12-18 | Traditional | PDF ↗ |
| K792176 | DRAPE, MICROSCOPE | Chris Co., Inc. | 1979-12-10 | Traditional | PDF ↗ |
| K791864 | INSTRUMENT PAD | Procter & Gamble Mfg. Co. | 1979-10-17 | Traditional | PDF ↗ |
| K791719 | BARRIER & FACE MASK WITH INNER FACING | Surgikos, Inc. | 1979-10-04 | Traditional | PDF ↗ |
| K791439 | BARRIER* OVERHEAD TABLE DRAPE | Surgikos, Inc. | 1979-08-28 | Traditional | PDF ↗ |
| K791500 | BARRIER *450* TAPE STRIP | Surgikos, Inc. | 1979-08-28 | Traditional | PDF ↗ |
| K791438 | BARRIER* C-ARM DRAPE | Surgikos, Inc. | 1979-08-28 | Traditional | PDF ↗ |
| K791486 | FABRIC 450* TOWEL DRAPE | Surgikos, Inc. | 1979-08-28 | Traditional | PDF ↗ |
| K791440 | BARRIER* X-RAY CASSETTE DRAPE | Surgikos, Inc. | 1979-08-28 | Traditional | PDF ↗ |
| K780627 | SURG-O-PAK, GOWNS, SHEETS, AND TOWELS | Convertors | 1979-07-11 | Traditional | PDF ↗ |
| K790970 | SURGICAL FACE MASK | Carapace, Inc. | 1979-07-03 | Traditional | PDF ↗ |
| K791070 | ACCU-SORB STERILE STOCKINETTES | Medline Industries, Inc. | 1979-06-20 | Traditional | PDF ↗ |
| K791032 | CARDIAC CATHETERIZATION SHEETS/PACKS | Surgikos, Inc. | 1979-06-15 | Traditional | PDF ↗ |
Product code KKX · Class II · General, Plastic Surgery. Data: openFDA.