MODIFICATION TO AUTO-BAND LIGATOR
FDA 510(k) clearance K083556 · decided 2009-02-19
Clearance details
- K-number
- K083556
- Device name
- MODIFICATION TO AUTO-BAND LIGATOR
- Applicant
- Scandimed International
- Decision
- Substantially Equivalent
- Date received
- 2008-12-02
- Decision date
- 2009-02-19
- Days to decision
- 79 days
- Clearance type
- Special
- Product code
- MND
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jamestown, RI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Scandimed International
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.
| Record | Firm | Date |
|---|---|---|
| AUTOBAND LIGATOR (K132535) | Endochoice, Inc. | 2013-08-23 |
| 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 |
| BARD RAPIDFIRE MULTIPLE BAND LIGATOR (K971137) | C.R. Bard, Inc. | 1997-10-16 |
Recalls involving this device
No recalls on record reference this clearance.