510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010277Substantially Equivalent

Ams Fascial-Anchoring System

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

K010277 is the FDA 510(k) clearance record for AMS FASCIAL-ANCHORING SYSTEM, a class II device, cleared for American Medical Systems, Inc. on under FDA product code NEH (Anchor, Fascial). FDA records list 82 510(k) clearances for American Medical Systems, Inc., from to . As of , FDA records show no recalls naming K010277.

Clearance record

Decision date
Received
(55 days to decision)
Product code
NEH Anchor, Fascial
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
American Medical Systems, Inc. 10700 Bren Rd. W., Minnetonka MN
510(k) summary
Summary
Third party review
No

Clearances, product code NEH

Trailing 12 months

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

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