510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953830Substantially Equivalent

Kensorb

Kentron Health Care, Inc., Hollywood FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953830 is the FDA 510(k) clearance record for KENSORB, a class I device, cleared for Kentron Health Care, Inc. on under FDA product code GDY (Gauze/Sponge, Internal, X-Ray Detectable). FDA records list 6 510(k) clearances for Kentron Health Care, Inc., from to . As of , FDA records show no recalls naming K953830.

Clearance record

Decision date
Received
(48 days to decision)
Product code
GDY Gauze/Sponge, Internal, X-Ray Detectable
Regulation
21 CFR 878.4450
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Kentron Health Care, Inc. 4330 Sheridan St., Hollywood FL
510(k) summary
Statement
Third party review
No

Clearances, product code GDY

Trailing 12 months

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

FDA records show no clearances under product code GDY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDY, 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