510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K843056Substantially Equivalent

Elastic Bandage

Sterile Medical Systems, South Weymouth MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843056 is the FDA 510(k) clearance record for ELASTIC BANDAGE, a class I device, cleared for Sterile Medical Systems on under FDA product code GAX (Tourniquet, Nonpneumatic). FDA records list one 510(k) clearance for Sterile Medical Systems. As of , FDA records show no recalls naming K843056.

Clearance record

Decision date
Received
(123 days to decision)
Product code
GAX Tourniquet, Nonpneumatic
Regulation
21 CFR 878.5900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sterile Medical Systems 541 Main St., South Weymouth MA
Third party review
No

Clearances, product code GAX

Trailing 12 months

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

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