510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896505Substantially Equivalent

Porges Universal Handles

Porges Corp., Gary IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896505 is the FDA 510(k) clearance record for PORGES UNIVERSAL HANDLES, a class II device, cleared for Porges Corp. on under FDA product code GCP (Endoscope, Ac-Powered And Accessories). FDA records list 22 510(k) clearances for Porges Corp., from to . As of , FDA records show no recalls naming K896505.

Clearance record

Decision date
Received
(76 days to decision)
Product code
GCP Endoscope, Ac-Powered And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Porges Corp. 5700 W. 23rd Ave., Gary IN
Third party review
No

Clearances, product code GCP

Trailing 12 months

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

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