NAB · Gauze / Sponge,Nonresorbable For External Use
General, Plastic Surgery · 21 CFR 878.4014 · Class 1
Overview
| Product Code | NAB |
|---|---|
| Device Name | Gauze / Sponge,Nonresorbable For External Use |
| Regulation | 21 CFR 878.4014 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 88)
Showing 20 most recent of 88 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K946015 | IVALON EXTERNAL SPONGE | Ivalon | Feb 27, 1995 | SESE |
| K940755 | ISOLYER (4X4, 8PLY) | Isolyer Co. | May 2, 1994 | SESE |
| K931610 | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON | Omni Mfg., Inc. | Jun 24, 1993 | SESE |
| K925590 | MULTI-TRAUMA DRESSING | Gam Industries, Inc. | Apr 8, 1993 | SESE |
| K926072 | K-BAND AND K-CREPE | Parema , Ltd. | Mar 19, 1993 | SESE |
| K915591 | STERILE GAUZE PADS | Eagle Medical, Inc. | Jan 27, 1993 | SESE |
| K924650 | GAUZE SPONGES | Dav-Mar Medical Products, Inc. | Jan 11, 1993 | SESE |
| K923602 | ABSORBENT PAD -- MODIFICATION | Winfield Laboratories, Inc. | Dec 7, 1992 | SESE |
| K923115 | CLINISORB | Hermitage Hospital Products, Inc. | Nov 23, 1992 | SESE |
| K923378 | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | Oct 6, 1992 | SESE |
| K923116 | COMBINE II WETPROOF PAD | Hermitage Hospital Products, Inc. | Oct 6, 1992 | SESE |
| K923846 | BURN DRESSING | Medical Action Industries, Inc. | Sep 11, 1992 | SESE |
| K921227 | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | May 29, 1992 | SESE |
| K920282 | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | May 29, 1992 | SESE |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | May 29, 1992 | SESE |
| K920269 | EZ GAUZE SPONGE | Cal West Trading Co. | Apr 22, 1992 | SESE |
| K915822 | MULTIPLE DRESSING, STERILE NONADDHERENT PADS | Kerma Medical Products, Inc. | Mar 26, 1992 | SESE |
| K914604 | MEPITEL NON-ADHERENT SILICONE DRESSING | Molnlycke Clinical Products AB | Mar 25, 1992 | SESE |
| K914937 | STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES | Kerma Medical Products, Inc. | Dec 4, 1991 | SESE |
| K914842 | GAUZE BANDAGE ROLL | Cal West Trading Co. | Dec 4, 1991 | SESE |
Top Applicants
- Stan-Pak Ent. — 9 clearances
- Cal West Trading Co. — 8 clearances
- Kerma Medical Products, Inc. — 4 clearances
- Hermitage Hospital Products, Inc. — 4 clearances
- Ulti-Med Intl., Inc. — 3 clearances
