Atlas FDA

Cook Cystostomy Catheter Set

FDA 510(k) clearance K181097 · decided 2019-01-18

Clearance details

K-number
K181097
Device name
Cook Cystostomy Catheter Set
Applicant
Cook Incorporated
Decision
Unknown
Date received
2018-04-26
Decision date
2019-01-18
Days to decision
267 days
Clearance type
Traditional
Product code
KOB
Device class
2
Regulation number
876.5090
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Bloomington, IN, 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
AMT Low-Profile Suprapubic Catheter & Drainage Set (K240514)Applied Medical Technology, Inc.2024-11-01
One-Step Suprapubic Introducer (K182709)Cook Incorporated2018-12-26
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (K182066)Cook Incorporated2018-10-30
SUPRAPUBIC CATHETER AND INTRODUCER SET (K132890)Mediplus , Ltd.2014-01-17
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM (K120127)Swan Valley Medical, Incorporated2012-10-26
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (K014002)Fortune Medical Instrument Corp.2002-03-04
LOWSLEY SUPRAPUBIC TRACTOR (K012153)Circon Video2001-09-19
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (K970969)The Kendal Co.1997-04-23
RUSCH SUPRAPUBIC TRAY (K970021)Rusch, Inc.1997-02-07
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (K945480)Harry A. Schlakman1995-08-28
LINDNER/GOLOMB SP INTRODUCING SOUND (K953024)Cook Urological, Inc.1995-08-18
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE (K952187)Rusch, Inc.1995-07-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005)Cook Incorporated2009-04-02
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006)Cook Incorporated2009-03-05
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004)Cook Incorporated2008-05-08
COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002)Cook Incorporated2000-06-12
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001)Cook Incorporated1998-07-08
COOK CHORIONIC VILLUS SAMPLING SET (P900007)Cook Incorporated1994-09-30