510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K830917Substantially Equivalent

Surgitek Sizer for Penile Prosthesis

Medical Engineering Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830917 is the FDA 510(k) clearance record for SURGITEK SIZER FOR PENILE PROSTHESIS, a class II device, cleared for Medical Engineering Corp. on under FDA product code FAE (Prosthesis, Penile). FDA records list 28 510(k) clearances for Medical Engineering Corp., from to . As of , FDA records show no recalls naming K830917.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FAE Prosthesis, Penile
Regulation
21 CFR 876.3630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Engineering Corp. 803 N. Front St. Suite 3, Mchenry IL
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