Product code NAB
- Device name
- Gauze / Sponge,Nonresorbable For External Use
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4014
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946015 | IVALON EXTERNAL SPONGE | Ivalon | 1995-02-27 |
| K940755 | ISOLYER (4X4, 8PLY) | Isolyer Co. | 1994-05-02 |
| K931610 | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON | Omni Mfg., Inc. | 1993-06-24 |
| K925590 | MULTI-TRAUMA DRESSING | Gam Industries, Inc. | 1993-04-08 |
| K926072 | K-BAND AND K-CREPE | Parema , Ltd. | 1993-03-19 |
| K915591 | STERILE GAUZE PADS | Eagle Medical, Inc. | 1993-01-27 |
| K924650 | GAUZE SPONGES | Dav-Mar Medical Products, Inc. | 1993-01-11 |
| K923602 | ABSORBENT PAD -- MODIFICATION | Winfield Laboratories, Inc. | 1992-12-07 |
| K923115 | CLINISORB | Hermitage Hospital Products, Inc. | 1992-11-23 |
| K923116 | COMBINE II WETPROOF PAD | Hermitage Hospital Products, Inc. | 1992-10-06 |
| K923378 | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | 1992-10-06 |
| K923846 | BURN DRESSING | Medical Action Industries, Inc. | 1992-09-11 |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | 1992-05-29 |
| K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-05-29 |
| K921227 | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | 1992-05-29 |
| K920269 | EZ GAUZE SPONGE | Cal West Trading Co. | 1992-04-22 |
| K915822 | MULTIPLE DRESSING, STERILE NONADDHERENT PADS | Kerma Medical Products, Inc. | 1992-03-26 |
| K914604 | MEPITEL NON-ADHERENT SILICONE DRESSING | Molnlycke Clinical Products AB | 1992-03-25 |
| K913779 | BANDAGE ROLL, GAUZE | Keilei Intl., Inc. | 1991-12-04 |
| K914071 | MULTIPLE BURN DRESSING | Kerma Medical Products, Inc. | 1991-12-04 |
| K914431 | ABSORBENT FIBER | Ulti-Med Intl., Inc. | 1991-12-04 |
| K914842 | GAUZE BANDAGE ROLL | Cal West Trading Co. | 1991-12-04 |
| K914937 | STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES | Kerma Medical Products, Inc. | 1991-12-04 |
| K912692 | CONFORMING BANDAGE | Ulti-Med Intl., Inc. | 1991-10-04 |
| K912693 | POST OPERATIVE SPONGE | Ulti-Med Intl., Inc. | 1991-10-04 |
| K912950 | COMPRESS DRESSING | Cal West Trading Co. | 1991-10-04 |
| K912952 | BANDAGE COMPRESS | Cal West Trading Co. | 1991-10-04 |
| K912779 | GAUZE SPONGE,STERILE 2'S | Keilei Intl., Inc. | 1991-09-30 |
| K912953 | GAUZE COMPRESS | Cal West Trading Co. | 1991-09-30 |
| K912951 | 12-PLY GAUZE PAD | Cal West Trading Co. | 1991-09-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D832CFT11 | Plasdent | PLASDENT CORPORATION | 2026-10-13 |
| D832FT11 | Plasdent | PLASDENT CORPORATION | 2026-10-13 |
| D832SAP21 | Plasdent | PLASDENT CORPORATION | 2026-10-13 |
| D832SAP31 | Plasdent | PLASDENT CORPORATION | 2026-10-13 |
| D832SAPR21 | Plasdent | PLASDENT CORPORATION | 2026-10-13 |
| D832SAPR31 | Plasdent | PLASDENT CORPORATION | 2026-10-13 |
| M689HHMTG01020 | MiniTAC Gauze | Safeguard US Operating, LLC | 2026-10-13 |
| 00050428143117 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-10-10 |
| 00050428339763 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-10-10 |
| 00050428343869 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-10-10 |
| 50885380207219 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 50885380207202 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 10885380207174 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 10885380207167 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 10885380207150 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 50885380207226 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 50885380207233 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 50885380207240 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 50885380207257 | Curity | Cardinal Health 200, LLC | 2026-10-08 |
| 06975675784750 | RESCUE RESSENTIALS | EMSRUN GROUP | 2026-09-22 |
| 20192253039594 | Kerlix | Cardinal Health 200, LLC | 2025-03-19 |
| 20192253039396 | Kerlix | Cardinal Health 200, LLC | 2025-03-19 |
| 20192253039372 | Kerlix | Cardinal Health 200, LLC | 2025-03-19 |
| 20192253039365 | Kerlix | Cardinal Health 200, LLC | 2025-03-19 |
| 20192253039358 | Kerlix | Cardinal Health 200, LLC | 2025-03-19 |
| 20192253047155 | Curity | Cardinal Health 200, LLC | 2024-10-08 |
| 20192253047148 | Curity | Cardinal Health 200, LLC | 2024-07-15 |
| 20192253047186 | Curity | Cardinal Health 200, LLC | 2023-10-12 |
| 00885380173847 | Curity | Cardinal Health 200, LLC | 2020-10-23 |
| 00885380173748 | Curity | Cardinal Health 200, LLC | 2020-09-15 |