510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923378Substantially Equivalent

Usp Type VII Gauze Sponges

E.W.A., Ltd., Lakewood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923378 is the FDA 510(k) clearance record for USP TYPE VII GAUZE SPONGES, a class I device, cleared for E.W.A., Ltd. on under FDA product code NAB (Gauze / Sponge,Nonresorbable For External Use). FDA records list one 510(k) clearance for E.W.A., Ltd. As of , FDA records show no recalls naming K923378.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NAB Gauze / Sponge,Nonresorbable For External Use
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
E.W.A., Ltd. 164 Flint Rock Dr., Lakewood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code NAB

Trailing 12 months

FDA records hold no clearances under product code NAB in the trailing twelve months.

FDA records show no clearances under product code NAB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260