510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972091Substantially Equivalent

Ams Foreign Body Extrator

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

K972091 is the FDA 510(k) clearance record for AMS FOREIGN BODY EXTRATOR, a class II device, cleared for American Medical Systems, Inc. on under FDA product code FFL (Dislodger, Stone, Basket, Ureteral, Metal). FDA records list 82 510(k) clearances for American Medical Systems, Inc., from to . As of , FDA records show no recalls naming K972091.

Clearance record

Decision date
Received
(86 days to decision)
Product code
FFL Dislodger, Stone, Basket, Ureteral, Metal
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Medical Systems, Inc. 10700 Bren Rd. W., Minnetonka MN
510(k) summary
Summary
Third party review
No

Clearances, product code FFL

Trailing 12 months

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

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