Atlas FDA

LOWSLEY SUPRAPUBIC TRACTOR

FDA 510(k) clearance K012153 · decided 2001-09-19

Clearance details

K-number
K012153
Device name
LOWSLEY SUPRAPUBIC TRACTOR
Applicant
Circon Video
Decision
Substantially Equivalent
Date received
2001-07-11
Decision date
2001-09-19
Days to decision
70 days
Clearance type
Traditional
Product code
KOB
Device class
2
Regulation number
876.5090
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Santa Barbara, CA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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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
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.