Atlas FDA

PROSYS URIHESIVE SYSTEM LA

FDA 510(k) clearance K951530 · decided 1995-05-12

Clearance details

K-number
K951530
Device name
PROSYS URIHESIVE SYSTEM LA
Applicant
Convatec, A Division of E.R. Squibb & Sons
Decision
Substantially Equivalent
Date received
1995-04-03
Decision date
1995-05-12
Days to decision
39 days
Clearance type
Traditional
Product code
EXJ
Device class
1
Regulation number
876.5250
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Princeton, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BOUSER'S URINAL (K970465)General Polymers1997-12-18
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (K972100)Advanced Care Medical Products1997-07-31
COMFORT CATH CHOICE MALE EXTERNAL CATHETER (K970966)Sierra Laboratories, Inc.1997-04-22
PROSYS SAMEC LA (K963265)Convatec, A Division of E.R. Squibb & Sons1996-10-25
SELF RETAINING MALE EXTERNAL URINARY CATHETER (K962900)Hollister, Inc.1996-09-16
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (K962384)Sierra Laboratories, Inc.1996-07-15
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (K962413)Sierra Laboratories, Inc.1996-07-15
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (K952082)Rochester Medical Corp.1995-07-18
CLEAR ADVANTAGE II (K945628)Mentor Corp.1995-07-06
PROSYS URIHESICE SYSTEM NL (K950690)Convatec, A Division of E.R. Squibb & Sons1995-03-23
CONQUEST MALE CONTINENCE SYSTEM (K942941)Convatec, A Bristol-Myers Squibb Co.1995-03-17
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER (K946243)Coloplast A/S1995-02-13

Recalls involving this device

No recalls on record reference this clearance.