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 |
| K923378 | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | 1992-10-06 |
| K923116 | COMBINE II WETPROOF PAD | Hermitage Hospital Products, Inc. | 1992-10-06 |
| K923846 | BURN DRESSING | Medical Action Industries, Inc. | 1992-09-11 |
| K921227 | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | 1992-05-29 |
| K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-05-29 |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, 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 |
| K914071 | MULTIPLE BURN DRESSING | Kerma Medical Products, Inc. | 1991-12-04 |
| K913779 | BANDAGE ROLL, GAUZE | Keilei Intl., 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 |
| K912693 | POST OPERATIVE SPONGE | Ulti-Med Intl., Inc. | 1991-10-04 |
| K912692 | CONFORMING BANDAGE | 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 |
| K912953 | GAUZE COMPRESS | Cal West Trading Co. | 1991-09-30 |
| K912779 | GAUZE SPONGE,STERILE 2'S | Keilei Intl., Inc. | 1991-09-30 |
| K912951 | 12-PLY GAUZE PAD | Cal West Trading Co. | 1991-09-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06924105625033 | BOENMED | BOEN HEALTHCARE CO., LTD. | 2026-06-03 |
| 06924105625026 | BOENMED | BOEN HEALTHCARE CO., LTD. | 2026-06-03 |
| G242YCAKMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-09 |
| G242YCADMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-09 |
| G242YCALMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCAJMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCAHMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCAGMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCAEMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCACMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCABMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCAAMR9 | Techno-Aide | Techno-Aide, Inc. | 2025-09-05 |
| G242YCAB9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242CCCDR9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242CCL149 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242CCM109 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242YCAG9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242CCXL249 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242YCAE9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242CCXZ249 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242YCAD9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242CCZ149 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242YCAC9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242YCAA9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| G242YCAH9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-10 |
| G242YCAJ9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-10 |
| G242YCAK9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-10 |
| G242YCAL9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-10 |
| G018WC90122411 | Wound-Care | Supply Line International Medical, LLC | 2020-12-21 |
| G018WC90122311 | Wound-Care | Supply Line International Medical, LLC | 2020-12-21 |