NAB — Gauze / Sponge,Nonresorbable For External Use Class I
FDA product code NAB covers "Gauze / Sponge,Nonresorbable For External Use", a Class I medical device regulated under 21 CFR 878.4014. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NAB
- Device Class
- Class I
- Regulation Number
- 878.4014
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K946015 | ivalon | IVALON EXTERNAL SPONGE | February 27, 1995 |
| K940755 | isolyer | ISOLYER (4X4, 8PLY) | May 2, 1994 |
| K931610 | omni mfg | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON | June 24, 1993 |
| K925590 | gam industries | MULTI-TRAUMA DRESSING | April 8, 1993 |
| K926072 | parema | K-BAND AND K-CREPE | March 19, 1993 |
| K915591 | eagle medical | STERILE GAUZE PADS | January 27, 1993 |
| K924650 | dav-mar medical products | GAUZE SPONGES | January 11, 1993 |
| K923602 | winfield laboratories | ABSORBENT PAD -- MODIFICATION | December 7, 1992 |
| K923115 | hermitage hospital products | CLINISORB | November 23, 1992 |
| K923378 | e.w.a | USP TYPE VII GAUZE SPONGES | October 6, 1992 |
| K923116 | hermitage hospital products | COMBINE II WETPROOF PAD | October 6, 1992 |
| K923846 | medical action industries | BURN DRESSING | September 11, 1992 |
| K920282 | trinity laboratories | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | May 29, 1992 |
| K915821 | kerma medical products | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | May 29, 1992 |
| K921227 | courtaulds fibers | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | May 29, 1992 |
| K920269 | cal west trading | EZ GAUZE SPONGE | April 22, 1992 |
| K915822 | kerma medical products | MULTIPLE DRESSING, STERILE NONADDHERENT PADS | March 26, 1992 |
| K914604 | molnlycke clinical products | MEPITEL NON-ADHERENT SILICONE DRESSING | March 25, 1992 |
| K914842 | cal west trading | GAUZE BANDAGE ROLL | December 4, 1991 |
| K914431 | ulti-med intl | ABSORBENT FIBER | December 4, 1991 |