510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952082Substantially Equivalent

Rochester Medical Corporation Silicone Male External Catheter

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

K952082 is the FDA 510(k) clearance record for ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER, a class I device, cleared for Rochester Medical Corp. on under FDA product code EXJ (Device, Incontinence, Urosheath Type, Sterile). FDA records list 13 510(k) clearances for Rochester Medical Corp., from to . As of , FDA records show no recalls naming K952082.

Clearance record

Decision date
Received
(76 days to decision)
Product code
EXJ Device, Incontinence, Urosheath Type, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Rochester Medical Corp. 1500 2nd Ave. Northwest, Stewartville MN
510(k) summary
Statement
Third party review
No

Clearances, product code EXJ

Trailing 12 months

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

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