510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971627Substantially Equivalent

Silicone Antibacterial Foley Catheter

Rochester Medical Corp., Stewartville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971627 is the FDA 510(k) clearance record for SILICONE ANTIBACTERIAL FOLEY CATHETER, a class II device, cleared for Rochester Medical Corp. on under FDA product code MJC (Catheter, Urological (Antimicrobial) And Accessories). FDA records list 13 510(k) clearances for Rochester Medical Corp., from to . As of , FDA records show no recalls naming K971627.

Clearance record

Decision date
Received
(256 days to decision)
Product code
MJC Catheter, Urological (Antimicrobial) And Accessories
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rochester Medical Corp. One Rochester Medical Dr., Stewartville MN
510(k) summary
Summary
Third party review
No

Clearances, product code MJC

Trailing 12 months

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

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