510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884838Substantially Equivalent

Allen Prone Armboard

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

K884838 is the FDA 510(k) clearance record for ALLEN PRONE ARMBOARD, a class I device, cleared for Edgewater Medical Systems, Inc. on under FDA product code BTX (Board, Arm (With Cover), Sterile). FDA records list 2 510(k) clearances for Edgewater Medical Systems, Inc., from to . As of , FDA records show no recalls naming K884838.

Clearance record

Decision date
Received
(24 days to decision)
Product code
BTX Board, Arm (With Cover), Sterile
Regulation
21 CFR 878.3910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Edgewater Medical Systems, Inc. 6263 Mayfield Rd. #206, Mayfield Hts. OH
Third party review
No

Clearances, product code BTX

Trailing 12 months

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

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