510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NABClass I

Gauze / Sponge,Nonresorbable For External Use

21 CFR 878.4014 / General, Plastic Surgery
FDA source (opens on fda.gov)

NAB is the FDA product code for Gauze / Sponge,Nonresorbable For External Use, a class I device type, regulated under 21 CFR 878.4014. As of , FDA records hold 88 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
NAB
Device name
Gauze / Sponge,Nonresorbable For External Use
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
88
Ingested recalls
6

Clearances, product code NAB

By decision year
88 clearances under product code NAB with a decision year between 1976 and 1995, 1982 the highest year at 18.
Show the numbers
510(k) clearances under FDA product code NAB by decision year
YearClearances
19761
19771
19785
19793
19802
19815
198218
19838
19841
19861
19872
19881
19897
199115
199211
19935
19941
19951

Applicants with the most clearances

Product code NAB
Applicants holding the most 510(k) clearances under product code NAB
ApplicantClearances
Stan-Pak Ent.9
Cal West Trading Co.8
Hermitage Hospital Products, Inc.4
Kerma Medical Products, Inc.4
Kendall Research Center3
North Health Care3
Pac-Kit Safety Equipment Co.3
Ulti-Med Intl., Inc.3
Abco Dealers, Inc.2
Howmedica Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 550 companies shown, in name order