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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K913408 | STERILE PLASTIC DRAPE | Acacia Laboratories, Inc. | 1992-03-12 | Traditional | PDF ↗ |
| K913448 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | Graham Medical Products | 1992-02-07 | Traditional | PDF ↗ |
| K913447 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | Graham Medical Products | 1992-02-07 | Traditional | PDF ↗ |
| K913486 | QUALTEX SURGICAL DRAPE, MODIFICATION | Deroyal Industries, Inc. | 1992-02-05 | Traditional | PDF ↗ |
| K914929 | LACERATION TRAY | Westmark Hospital Supplies | 1992-01-31 | Traditional | PDF ↗ |
| K914605 | MULTIPLE STERILE SURGICAL DRAPE PACK | Assured Surgical Products, Inc. | 1992-01-15 | Traditional | PDF ↗ |
| K915214 | ARTHROSCOPY CAMERA DRAPE | O.R. Concepts, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K914369 | QUALTEX MAGNETIC INSTRUMENT DRAPE | Deroyal Industries, Inc. | 1991-12-02 | Traditional | PDF ↗ |
| K913536 | PRC AUTOPSY DEVICE | Pennstate | 1991-11-22 | Traditional | PDF ↗ |
| K913506 | CONVERTORS SAFECARE GOWN & DRAPE MATERIAL | Baxter Healthcare Corp | 1991-10-11 | Traditional | PDF ↗ |
| K913382 | MEGA PARACENTESIS KIT | Mega Medical, Inc. | 1991-10-08 | Traditional | PDF ↗ |
| K911944 | MEDI GUARD DENTAL BIB | Sancella, Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K913047 | STERILESERT(TM) CABLE AND POLE DRAPE | Arch Development Group | 1991-10-02 | Traditional | PDF ↗ |
| K912947 | STARPAC O.R. TOWEL | Multi M Intl., Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K911131 | STERILE SURGICAL GOWN PACK | Central Georgia Ancillary Health Systems | 1991-09-16 | Traditional | PDF ↗ |
| K904873 | STERILE SURGICAL PACK | Angelica Healthcare Services | 1991-08-29 | Traditional | PDF ↗ |
| K912490 | CITATION MEDICAL SCOPE PROCEDURE PACK | Citation Medical Corp. | 1991-08-16 | Traditional | PDF ↗ |
| K911565 | CUSTOM PROCEDURE TRAY | Vanguard Medical Concepts, Inc. | 1991-08-09 | Traditional | PDF ↗ |
| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Andronic Devices, Ltd. | 1991-08-02 | Traditional | PDF ↗ |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | Andronic Devices, Ltd. | 1991-08-02 | Traditional | PDF ↗ |
| K912110 | DISPOSABLE O.R. TOWEL | American Threshold Industries, Inc. | 1991-07-25 | Traditional | PDF ↗ |
| K912542 | PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS | Puritas Health Care, Inc. | 1991-07-23 | Traditional | PDF ↗ |
| K911509 | MAGNA OBSTETRICAL PACKS | Dms Miami, Inc. | 1991-06-17 | Traditional | PDF ↗ |
| K911510 | MAGNA SURGICAL PACKS | Dms Miami, Inc. | 1991-06-17 | Traditional | PDF ↗ |
| K905803 | HALE SUN SURGICAL TOWEL OR O.R. TOWEL | Hale Sun Industries, Ltd. | 1991-05-21 | Traditional | PDF ↗ |
| K911039 | INVOTEC EAR DRAPE | Invotec International, Inc. | 1991-05-13 | Traditional | PDF ↗ |
| K910084 | SURGICAL DRAPE | Biocor Medical, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K904957 | STERILE AND NON-STERILE TEXTILE PACKS | Surgical Pack Services, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K905701 | RICHARD-ALLAN SHEET CLIP | Richard-Allan Medical | 1991-02-19 | Traditional | PDF ↗ |
| K910495 | QUALTEX SURGICAL DRAPE | Deroyal Industries, Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K905465 | STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE | Angiosystems, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K905466 | STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE | Angiosystems, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K904694 | CUSTOMED ANGIODRAPE PACK FEMORAL | Customed, Inc. | 1991-01-02 | Traditional | PDF ↗ |
| K904693 | CUSTOMED CARDIOVASCULAR PACK | Customed, Inc. | 1991-01-02 | Traditional | PDF ↗ |
| K903117 | ORION STERILE OR TOWELS | Orion Life Systems, Inc. | 1990-12-31 | Traditional | PDF ↗ |
| K904960 | QUALTEX SURGICAL DRAPE | Deroyal Industries, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K905005 | DISPOSABLE SURGICAL TOWEL (NON-STERILE) | Marand Products, Inc. | 1990-12-11 | Traditional | PDF ↗ |
| K903346 | DISPOSABLE EMISSIONS BARRIER LASER DRAPE | Wave-Form Systems, Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K902191 | CUSTOMED LAP PACK II | Customed, Inc. | 1990-10-31 | Traditional | PDF ↗ |
| K901705 | CUSTOMED CYSTO PACK II | Customed, Inc. | 1990-10-31 | Traditional | PDF ↗ |
| K904112 | STI DRAPE SHEET STYLE 1908 | Sterilizer Technologies Corp. | 1990-10-30 | Traditional | PDF ↗ |
| K903908 | REPAK SURGICAL PACKS | Repack Surgical Enterprises, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K902715 | SURGICAL TOWEL | Aztec Medical, Inc. | 1990-09-28 | Traditional | PDF ↗ |
| K902885 | CUSTOMED BASIC PACK II | Customed, Inc. | 1990-09-19 | Traditional | PDF ↗ |
| K902884 | CUSTOMED BASIC PACK I | Customed, Inc. | 1990-09-19 | Traditional | PDF ↗ |
| K902886 | CUSTOMED BASIC PACK III | Customed, Inc. | 1990-09-19 | Traditional | PDF ↗ |
| K903726 | DRAPE, SURGICAL - UTILITY DRAPE - STERILE | Graham Medical Products | 1990-08-27 | Traditional | PDF ↗ |
| K902384 | ABDOMINAL OR C-SECTION DRAPE SHEET | Medical Plastics, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K902030 | CUSTOMED LAP PACK III | Customed, Inc. | 1990-07-12 | Traditional | PDF ↗ |
| K902031 | CUSTOMED LAP PACK IV | Customed, Inc. | 1990-07-12 | Traditional | PDF ↗ |
| K902029 | CUSTOMED LAP PACK I | Customed, Inc. | 1990-07-12 | Traditional | PDF ↗ |
| K901465 | ABSORBABLE GAUZE DRAPE | Ulti-Med Intl., Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K900945 | LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING | Palex Medical, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K896215 | MERCY HIP/KNEE PACK | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-13 | Traditional | PDF ↗ |
| K897120 | EQUIP COVERS, STERILE | Amedic USA | 1990-01-04 | Traditional | PDF ↗ |
| K896367 | STERILE SURGICAL DRAPES AND SHEETS | Clinitech, Inc. | 1989-12-04 | Traditional | PDF ↗ |
| K895404 | UNDER BUTTOCKS DRAPE | Medical Plastics, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K895011 | TRIDENT DRAPE SUPPORT | Trident Medical Products, Inc. | 1989-09-15 | Traditional | PDF ↗ |
| K894764 | OR TOWEL PACKS | Advance Medical Designs, Inc. | 1989-08-18 | Traditional | PDF ↗ |
| K894436 | MASCOT O.R. TOWEL | Mascot, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K894433 | BATES BLANKET | Joe B. Bates, MD, FAAP | 1989-08-11 | Traditional | PDF ↗ |
| K893212 | THERMALAP | O.R. Concepts, Inc. | 1989-06-01 | Traditional | PDF ↗ |
| K884231 | SURGICAL 'LASER' DRAPE | Henley Intl. | 1989-04-20 | Traditional | PDF ↗ |
| K885099 | MULTIPLE (STERILE SURGICAL TOWELS) | Med-Tex, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K890101 | FEMORAL ANGIOGRAPHY DRAPE | Medical Plastics, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K890709 | O.R. TOWELS (STERILE) | Cypress Medical Products, Ltd. | 1989-03-14 | Traditional | PDF ↗ |
| K882643 | AM TM SYRGICAL DRAPES | Henley Intl. | 1989-03-03 | Traditional | PDF ↗ |
| K890471 | PMS ANGIO DRAPE | Professional Medical Services | 1989-02-27 | Traditional | PDF ↗ |
| K890006 | BAXTER STERILE TOWEL | Healthmed Corp. | 1989-01-24 | Traditional | PDF ↗ |
| K884057 | ELAN-E DISPOSABLE DRAPE | Aesculap Instruments Corp. | 1988-10-19 | Traditional | PDF ↗ |
| K884112 | CARETEX OR TOWEL | James River Corp. | 1988-10-13 | Traditional | PDF ↗ |
| K883424 | SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB | Intera Corp. | 1988-09-06 | Traditional | PDF ↗ |
| K882000 | PRO-FECT O.R. TOWEL | Network Trading Corp. | 1988-08-26 | Traditional | PDF ↗ |
| K882724 | MICROTEK PROBE DRAPE | Microbio-Medics, Inc. | 1988-08-03 | Traditional | PDF ↗ |
| K882494 | ELAN-E DISPOSALBE DRAPE | Dermacare Products, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | A Plus International, Inc. | 1988-04-29 | Traditional | PDF ↗ |
| K881479 | OPERATION ROOM TOWEL | Rahn Laboratories | 1988-04-14 | Traditional | PDF ↗ |
| K880513 | DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE | Taub Industries | 1988-03-11 | Traditional | PDF ↗ |
| K875153 | THIELER KIT | Taris Corp. | 1988-02-18 | Traditional | PDF ↗ |
| K874086 | 3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX | 3M Company | 1987-12-17 | Traditional | PDF ↗ |
| K873141 | LASER RESISTANT DRAPE | Baxter Healthcare Corp | 1987-10-23 | Traditional | PDF ↗ |
| K873313 | SURGICAL DRAPE | American Medical Technology, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K872757 | OPSITE SPECIALITY DRAPES | Smith & Nephew, Inc. | 1987-07-28 | Traditional | PDF ↗ |
| K872395 | CK 1600 SERIES, TOWELS | Currie Medical Specialties, Inc. | 1987-07-02 | Traditional | PDF ↗ |
| K871068 | DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER | Lifestream Int'L, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K864388 | MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY | Deroyal Industries, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K870123 | SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM | Avery Intl. | 1987-02-04 | Traditional | PDF ↗ |
| K870122 | SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM | Avery Intl. | 1987-02-04 | Traditional | PDF ↗ |
| K870124 | SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM | Avery Intl. | 1987-02-04 | Traditional | PDF ↗ |
| K865094 | LINEN (HUCK) TOWEL | The Eye Co-Op, Inc. | 1987-01-20 | Traditional | PDF ↗ |
| K864899 | SURGICAL DRAPE PACK | Webster Enterprises, Inc. | 1987-01-20 | Traditional | PDF ↗ |
| K864697 | CK 6000 SERIES, TOWELS | Currie Medical Specialties, Inc. | 1986-12-18 | Traditional | PDF ↗ |
| K864111 | STERILE FIELD #605 FENESTRATED STERILE FIELD #606 | Graham Medical Products | 1986-10-30 | Traditional | PDF ↗ |
| K863323 | SENGEWALD CATALOG NUMBER 55 66 01 | Sengewald/USA, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K863871 | OPERATING ROOM TOWELS - STERILE/NON STERILE | Med-Tex, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K863732 | SURGICAL DRAPE & DRAPE ACCESSORIES | Intera Corp. | 1986-10-23 | Traditional | PDF ↗ |
| K863512 | DRAPE STERICOVER | Sterimed, Inc. | 1986-09-30 | Traditional | PDF ↗ |
| K862801 | SPUNGUARD PLUS SURGICAL DRAPE | Kimberly-Clark Corp. | 1986-08-07 | Traditional | PDF ↗ |
| K862577 | LINEN (HUCK) TOWEL | Dimed, Intl. | 1986-07-23 | Traditional | PDF ↗ |
| K862438 | SURGICAL DRAPES AND DRAPE ACCESSORIES | Avery Intl. | 1986-07-16 | Traditional | PDF ↗ |
Product code KKX · Class II · General, Plastic Surgery. Data: openFDA.