510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802850Substantially Equivalent

Tecnol o.r. Tourniquet Cover

Tecnol New Jersey Wound Care, Inc., Hammonton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802850 is the FDA 510(k) clearance record for TECNOL O.R. TOURNIQUET COVER, a class I device, cleared for Tecnol New Jersey Wound Care, Inc. on under FDA product code EYR (Tourniquet, Gastro-Urology). FDA records list 35 510(k) clearances for Tecnol New Jersey Wound Care, Inc., from to . As of , FDA records show no recalls naming K802850.

Clearance record

Decision date
Received
(62 days to decision)
Product code
EYR Tourniquet, Gastro-Urology
Regulation
21 CFR 878.5900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Tecnol New Jersey Wound Care, Inc. 368 Fairview Ave., Hammonton NJ
Third party review
No

Clearances, product code EYR

Trailing 12 months

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

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