510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953812Substantially Equivalent

Gauze Sponge

Remington Medical, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953812 is the FDA 510(k) clearance record for GAUZE SPONGE, a class I device, cleared for Remington Medical, Inc. on under FDA product code KHR (Absorber, Saliva, Paper). FDA records list 19 510(k) clearances for Remington Medical, Inc., from to . As of , FDA records show no recalls naming K953812.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KHR Absorber, Saliva, Paper
Regulation
21 CFR 872.6050
Device class
Class I
Review panel
Dental
Applicant
Remington Medical, Inc. 8601 Dunwoody Pl., Suite 510, Atlanta GA
510(k) summary
Statement
Third party review
No

Clearances, product code KHR

Trailing 12 months

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

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