510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914431Substantially Equivalent

Absorbent Fiber

Ulti-Med Intl., Inc., Glendale Hts. IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914431 is the FDA 510(k) clearance record for ABSORBENT FIBER, a class I device, cleared for Ulti-Med Intl., Inc. on under FDA product code NAB (Gauze / Sponge,Nonresorbable For External Use). FDA records list 21 510(k) clearances for Ulti-Med Intl., Inc., from to . As of , FDA records show no recalls naming K914431.

Clearance record

Decision date
Received
(61 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
Ulti-Med Intl., Inc. 1688 Glen Ellyn Rd., Glendale Hts. IL
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