510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860177Substantially Equivalent

Allen Universal Stirrup

Edgewater Medical Equipment Systems, Mayfield Hts. OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860177 is the FDA 510(k) clearance record for ALLEN UNIVERSAL STIRRUP, a class I device, cleared for Edgewater Medical Equipment Systems on under FDA product code BWN (Table And Attachments, Operating-Room). FDA records list 3 510(k) clearances for Edgewater Medical Equipment Systems, from to . As of , FDA records show no recalls naming K860177.

Clearance record

Decision date
Received
(25 days to decision)
Product code
BWN Table And Attachments, Operating-Room
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Edgewater Medical Equipment Systems 6263 Mayfield Rd., Mayfield Hts. OH
Third party review
No

Clearances, product code BWN

Trailing 12 months

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

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