510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K863671Substantially Equivalent

Pennine Leg Bag 350Ml Cat.no.db3 & 500Ml.cat.#db5

Samco Industries, Inc., Stoughton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863671 is the FDA 510(k) clearance record for PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5, a class II device, cleared for Samco Industries, Inc. on under FDA product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter). FDA records list 2 510(k) clearances for Samco Industries, Inc., from to . As of , FDA records show no recalls naming K863671.

Clearance record

Decision date
Received
(14 days to decision)
Product code
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Samco Industries, Inc. P.O. Box 648, Stoughton MA
Third party review
No

Clearances, product code KNX

Trailing 12 months

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

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