510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K852127Substantially Equivalent

Amsco Uro-Endo Mobile Table

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

K852127 is the FDA 510(k) clearance record for AMSCO URO-ENDO MOBILE TABLE, a class I device, cleared for American Sterilizer Co. on under FDA product code KQS (Table, Cystometric, Non-Electric And Accessories). FDA records list 36 510(k) clearances for American Sterilizer Co., from to . As of , FDA records show no recalls naming K852127.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KQS Table, Cystometric, Non-Electric And Accessories
Regulation
21 CFR 876.4890
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
American Sterilizer Co. 2424 W. 23rd St., Erie PA
Third party review
No

Clearances, product code KQS

Trailing 12 months

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

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