HX-20/21-1 ENDOSCOPIC LIGATOR
FDA 510(k) clearance K964661 · decided 1997-10-30
Clearance details
- K-number
- K964661
- Device name
- HX-20/21-1 ENDOSCOPIC LIGATOR
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-20
- Decision date
- 1997-10-30
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- MND
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melville, NY, 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 |
| BARD RAPIDFIRE MULTIPLE BAND LIGATOR (K971137) | C.R. Bard, Inc. | 1997-10-16 |
Recalls involving this device
No recalls on record reference this clearance.