Atlas FDA

ADD-A-CATH

FDA 510(k) clearance K884061 · decided 1988-10-25

Clearance details

K-number
K884061
Device name
ADD-A-CATH
Applicant
Femcare , Ltd.
Decision
Substantially Equivalent
Date received
1988-09-26
Decision date
1988-10-25
Days to decision
29 days
Clearance type
Traditional
Product code
KOB
Device class
2
Regulation number
876.5090
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Nottingham, England, GB
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Femcare

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
Cook Cystostomy Catheter Set (K181097)Cook Incorporated2019-01-18
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Filshie Clip (Mark VI) System (P920046/S015)Femcare , Ltd.2024-12-03
Filshie Clip (Mark VI) System (P920046/S014)Femcare , Ltd.2024-09-16
Filshie Clip System (P920046/S013)Femcare , Ltd.2023-12-18
Filshie Clip (Mark VI) System (P920046/S012)Femcare , Ltd.2022-01-06
Filshie Clip (Mark VI) System (P920046/S011)Femcare , Ltd.2019-10-09
Sterishot II Mini Flishie Clip Applicator (P920046/S010)Femcare , Ltd.2017-05-26
FILSHIE CLIP(MARK VI) SYSTEM (P920046/S008)Femcare , Ltd.2016-12-02
FILSHIE CLIP (MARK VI) SYSTEM (P920046/S009)Femcare , Ltd.2016-09-09