510(k) K033245
- Device
- BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
- Applicant
- C.R. Bard, Inc.
- 510(k) number
- K033245
- Product code
- MND
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-06
- Date received
- 2003-10-07
- Regulation
- 876.4400
- Classification name
- Ligator, Esophageal
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- MICHAEL A PATZ
- Address
- 129 Concord Rd. Bldg. #3 Billerica MA US 01821 01821
FDA Registration Numbers#
- 1037905
- 3013557562
- 3010138349
- 9611680
- 8010047
- 3013440400
- 3017103427
- 3004837686
- 1320894
- 9614641
- 1223925
- 3005099803
- 3012042439
- 3011050570
- 3007305485
- 3010188783
- 3008797804
- 3014620201
- 3011570296
- 3007695959
- 3008040402
- 3012494290
- 3011347300
- 1528319
- 3014769442
- 3030733800
- 3008274780
Source Documents#
Other 510(k) Records For Product Code MND#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132535 | AUTOBAND LIGATOR | Endochoice, Inc. | 2013-08-23 |
| K083556 | MODIFICATION TO AUTO-BAND LIGATOR | Scandimed International | 2009-02-19 |
| K081142 | AUTO-BAND LIGATOR | Scandimed International | 2008-05-16 |
| K051950 | INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 | Ethicon Endo-Surgery, Inc. | 2005-10-07 |
| K031236 | AUTO-BAND LIGATOR | Scandimed. A.S. | 2003-11-14 |
| K022434 | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | C.R. Bard, Inc. | 2002-08-05 |
| K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | Olympus America, Inc. | 2001-12-11 |
| K001744 | OLYMPUS ENDOSCOPIC LIGATION DEVICE | Olympus America, Inc. | 2001-02-27 |
| K990864 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 | Boston Scientific Corp | 1999-06-11 |
| K984255 | OLYMPUS HX-20 SERIES LIGATING DEVICE | Olympus Corp of America | 1999-01-12 |
| K964661 | HX-20/21-1 ENDOSCOPIC LIGATOR | Olympus America, Inc. | 1997-10-30 |
| K971137 | BARD RAPIDFIRE MULTIPLE BAND LIGATOR | C.R. Bard, Inc. | 1997-10-16 |
| K944220 | WILSON COOK MULTIPLE BAND LIGATOR | Wilson-Cook Medical, Inc. | 1995-01-24 |
| K940661 | STIEGMANN-GOFF ENDOSCOPIC LIGATOR | C.R. Bard, Inc. | 1994-11-28 |