510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935356Substantially Equivalent

Captain's Chair Accessory to Amsco Surgical Tables

Amsco American Sterilizer Co., Erie PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935356 is the FDA 510(k) clearance record for CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES, a class I device, cleared for Amsco American Sterilizer Co. on under FDA product code FWW (Table, Operating-Room, Pneumatic). FDA records list one 510(k) clearance for Amsco American Sterilizer Co. As of , FDA records show no recalls naming K935356.

Clearance record

Decision date
Received
(139 days to decision)
Product code
FWW Table, Operating-Room, Pneumatic
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Amsco American Sterilizer Co. 2424 W. 23rd St., Erie PA
510(k) summary
Statement
Third party review
No

Clearances, product code FWW

Trailing 12 months

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

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