WILSON COOK MULTIPLE BAND LIGATOR
FDA 510(k) clearance K944220 · decided 1995-01-24
Clearance details
- K-number
- K944220
- Device name
- WILSON COOK MULTIPLE BAND LIGATOR
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-29
- Decision date
- 1995-01-24
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- MND
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, 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.
| Record | Firm | Date |
|---|---|---|
| AUTOBAND LIGATOR (K132535) | Endochoice, Inc. | 2013-08-23 |
| MODIFICATION TO AUTO-BAND LIGATOR (K083556) | Scandimed International | 2009-02-19 |
| AUTO-BAND LIGATOR (K081142) | Scandimed International | 2008-05-16 |
| INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 (K051950) | Ethicon Endo-Surgery, Inc. | 2005-10-07 |
| AUTO-BAND LIGATOR (K031236) | Scandimed. A.S. | 2003-11-14 |
| BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K033245) | C.R. Bard, Inc. | 2003-11-06 |
| BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K022434) | C.R. Bard, Inc. | 2002-08-05 |
| HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K013066) | Olympus America, Inc. | 2001-12-11 |
| OLYMPUS ENDOSCOPIC LIGATION DEVICE (K001744) | Olympus America, Inc. | 2001-02-27 |
| SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 (K990864) | Boston Scientific Corp | 1999-06-11 |
| OLYMPUS HX-20 SERIES LIGATING DEVICE (K984255) | Olympus Corp of America | 1999-01-12 |
| HX-20/21-1 ENDOSCOPIC LIGATOR (K964661) | Olympus America, Inc. | 1997-10-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station R recall (Z-0092-2011) | Cook Endoscopy | 2010-10-19 |
| Four Shooter Saeed Multi-Band Ligator recall (Z-0536-04) | Wilson-Cook Medical Inc | 2004-07-20 |