510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912934Substantially Equivalent

Ams Sphincter 800 Urinary Prosthesis

American Medical Systems, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912934 is the FDA 510(k) clearance record for AMS SPHINCTER 800 URINARY PROSTHESIS, a class III device, cleared for American Medical Systems, Inc. on under FDA product code FAG (Prosthesis, Urethral Sphincter). FDA records list 82 510(k) clearances for American Medical Systems, Inc., from to . As of , FDA records show no recalls naming K912934.

Clearance record

Decision date
Received
(257 days to decision)
Product code
FAG Prosthesis, Urethral Sphincter
Device class
Class III
Review panel
Unknown
Applicant
American Medical Systems, Inc. 11001 Bren Rd. E., Minnetonka MN
510(k) summary
Summary
Third party review
No

Clearances, product code FAG

Trailing 12 months

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

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