FDA product code NAB: Gauze / Sponge,Nonresorbable For External Use
NAB is the FDA product code for gauze / sponge,nonresorbable for external use. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel. FDA has cleared 88 510(k) submissions under NAB, from 52 different applicants. The average 510(k) review took 69 days (median 61). FDA has posted 6 recalls for NAB devices.
Classification
| Field | Value |
|---|---|
| Device name | Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class I |
| Regulation | 21 CFR 878.4014 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NAB clearance
Top NAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stan-Pak Ent. | 9 | 1982-02-12 |
| Cal West Trading Co. | 8 | 1992-04-22 |
| Hermitage Hospital Products, Inc. | 4 | 1992-11-23 |
| Kerma Medical Products, Inc. | 4 | 1992-05-29 |
| Ulti-Med Intl., Inc. | 3 | 1991-12-04 |
47 more applicants have NAB clearances. See the full list in Caduvo.
Most recent NAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K946015 | Ivalon | IVALON EXTERNAL SPONGE | 1995-02-27 | 80 |
| K940755 | Isolyer Co. | ISOLYER (4X4, 8PLY) | 1994-05-02 | 73 |
| K931610 | Omni Mfg., Inc. | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON | 1993-06-24 | 84 |
| K925590 | Gam Industries, Inc. | MULTI-TRAUMA DRESSING | 1993-04-08 | 154 |
| K926072 | Parema , Ltd. | K-BAND AND K-CREPE | 1993-03-19 | 108 |
Recalls for NAB devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-11-05.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system
Frequently asked questions
What is FDA product code NAB?
NAB is the FDA product code for gauze / sponge,nonresorbable for external use. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel.
What device class is NAB?
Class I, regulation 21 CFR 878.4014. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NAB?
Across 88 cleared submissions the average was 69 days from receipt to decision (median 61).
Which companies have the most NAB clearances?
Stan-Pak Ent. (9); Cal West Trading Co. (8); Hermitage Hospital Products, Inc. (4); Kerma Medical Products, Inc. (4); Ulti-Med Intl., Inc. (3).
Have NAB devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2020-11-05.
Next steps
- Run an FDA pathway report with predicate devices for product code NAB
- Run a recall and safety report across every NAB manufacturer
- Watch product code NAB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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