510(k) K132890
- Device
- SUPRAPUBIC CATHETER AND INTRODUCER SET
- Applicant
- MEDIPLUS LTD.
- 510(k) number
- K132890
- Product code
- KOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-01-17
- Date received
- 2013-09-16
- Regulation
- 876.5090
- Classification name
- Catheter, Suprapubic (and Accessories)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL DRYDEN
- Address
- Unit 7, The Gateway Centre Coronation Rd., Cressex Bus. Pk. High Wycombe, Bucks GB HP12 35U HP12 35U
FDA Registration Numbers#
- 8022978
- 3013557562
- 1718873
- 3013247477
- 3009057691
- 1825146
- 3009688853
- 3011137372
- 9617192
- 1048735
- 3005987240
- 8021955
- 2528981
- 3011050570
- 3014656749
- 3030446844
- 3010400865
- 1820334
- 3022516937
- 3030733800
- 1526012
- 3004365956
- 1519132
- 3003790304
Source Documents#
Other 510(k) Records For Product Code KOB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024-11-01 |
| K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019-01-18 |
| K182709 | One-Step Suprapubic Introducer | Cook Incorporated | 2018-12-26 |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | 2018-10-30 |
| K120127 | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM | Swan Valley Medical, Incorporated | 2012-10-26 |
| K014002 | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | Fortune Medical Instrument Corp. | 2002-03-04 |
| K012153 | LOWSLEY SUPRAPUBIC TRACTOR | Circon Video | 2001-09-19 |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | The Kendal Co. | 1997-04-23 |
| K970021 | RUSCH SUPRAPUBIC TRAY | Rusch, Inc. | 1997-02-07 |
| K945480 | MOSS(R) STEEL BREAKAWAY(R) INTRODUCER | Harry A. Schlakman | 1995-08-28 |
| K953024 | LINDNER/GOLOMB SP INTRODUCING SOUND | Cook Urological, Inc. | 1995-08-18 |
| K952187 | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE | Rusch, Inc. | 1995-07-25 |
| K921071 | DENTOLOCK | Dentmed , Ltd. | 1992-03-26 |
| K904798 | SUPRAPUBIC FLOW CONTROLLER | Olympus Corp. | 1991-11-22 |
| K904434 | SEXTON CYSTOTOMY URINE PUMP (SCUP2) | Phoenix Bioengineering, Inc. | 1991-02-01 |
Legacy Summary#
summary
FDA Review#
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