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
K881097Substantially Equivalent

Spec 5* Suprapubic Catheter

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

K881097 is the FDA 510(k) clearance record for SPEC 5* SUPRAPUBIC CATHETER, a class II device, cleared for Porges Corp. on under FDA product code KOB (Catheter, Suprapubic (And Accessories)). FDA records list 22 510(k) clearances for Porges Corp., from to . As of , FDA records show no recalls naming K881097.

Clearance record

Decision date
Received
(80 days to decision)
Product code
KOB Catheter, Suprapubic (And Accessories)
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Porges Corp. 56 Westcott Rd., Stamford CT
Third party review
No

Clearances, product code KOB

Trailing 12 months

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

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