510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960949Substantially Equivalent

Prosys Bedside Drainage Bag (Sterile) Model 650167

Bristol-Myers Squibb, Skillman NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960949 is the FDA 510(k) clearance record for PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167, a class II device, cleared for Bristol-Myers Squibb on under FDA product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter). FDA records list one 510(k) clearance for Bristol-Myers Squibb. As of , FDA records show no recalls naming K960949.

Clearance record

Decision date
Received
(39 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
Bristol-Myers Squibb 100 Headquarters Park Dr., Skillman NJ
510(k) summary
Summary
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