510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910214Substantially Equivalent

Ams 700 Ultrex(tm) Preconnected Penile Prosthesis

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

K910214 is the FDA 510(k) clearance record for AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS, a class II device, cleared for American Medical Corp. on under FDA product code FAE (Prosthesis, Penile). FDA records list 3 510(k) clearances for American Medical Corp., from to . As of , FDA records show no recalls naming K910214.

Clearance record

Decision date
Received
(98 days to decision)
Product code
FAE Prosthesis, Penile
Regulation
21 CFR 876.3630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Medical Corp. 11001 Bren Rd. E., Minnetonka MN
Third party review
No

Clearances, product code FAE

Trailing 12 months

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

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