510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923116Substantially Equivalent

Combine II Wetproof Pad

Hermitage Hospital Products, Inc., Niantic CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923116 is the FDA 510(k) clearance record for COMBINE II WETPROOF PAD, a class I device, cleared for Hermitage Hospital Products, Inc. on under FDA product code NAB (Gauze / Sponge,Nonresorbable For External Use). FDA records list 8 510(k) clearances for Hermitage Hospital Products, Inc., from to . As of , FDA records show no recalls naming K923116.

Clearance record

Decision date
Received
(103 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
Hermitage Hospital Products, Inc. 38 Hope St., Niantic CT
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