510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834347Substantially Equivalent

Flexi-Flate Penile Implant

Surgitek, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834347 is the FDA 510(k) clearance record for FLEXI-FLATE PENILE IMPLANT, a class II device, cleared for Surgitek on under FDA product code FAE (Prosthesis, Penile). FDA records list 29 510(k) clearances for Surgitek, from to . As of , FDA records show no recalls naming K834347.

Clearance record

Decision date
Received
(111 days to decision)
Product code
FAE Prosthesis, Penile
Regulation
21 CFR 876.3630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgitek 4221 Richmond Rd., NW, Walker MI
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