MND — Ligator, Esophageal Class II
FDA product code MND covers "Ligator, Esophageal", a Class II medical device regulated under 21 CFR 876.4400. Submissions are reviewed by the Gastroenterology, Urology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MND
- Device Class
- Class II
- Regulation Number
- 876.4400
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K132535 | endochoice | AUTOBAND LIGATOR | August 23, 2013 |
| K083556 | scandimed international | MODIFICATION TO AUTO-BAND LIGATOR | February 19, 2009 |
| K081142 | scandimed international | AUTO-BAND LIGATOR | May 16, 2008 |
| K051950 | ethicon endo-surgery | INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 | October 7, 2005 |
| K031236 | scandimed. a.s | AUTO-BAND LIGATOR | November 14, 2003 |
| K033245 | c.r. bard | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | November 6, 2003 |
| K022434 | c.r. bard | BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U | August 5, 2002 |
| K013066 | olympus america | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | December 11, 2001 |
| K001744 | olympus america | OLYMPUS ENDOSCOPIC LIGATION DEVICE | February 27, 2001 |
| K990864 | boston scientific | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 | June 11, 1999 |
| K984255 | olympus corp of america | OLYMPUS HX-20 SERIES LIGATING DEVICE | January 12, 1999 |
| K964661 | olympus america | HX-20/21-1 ENDOSCOPIC LIGATOR | October 30, 1997 |
| K971137 | c.r. bard | BARD RAPIDFIRE MULTIPLE BAND LIGATOR | October 16, 1997 |
| K944220 | wilson-cook medical | WILSON COOK MULTIPLE BAND LIGATOR | January 24, 1995 |
| K940661 | c.r. bard | STIEGMANN-GOFF ENDOSCOPIC LIGATOR | November 28, 1994 |