Product code MND— Gastroenterology, Urology
AUTO-BAND LIGATOR
- Classification name
- Ligator, Esophageal
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code MND
FDA has cleared devices under product code MND between 1994 and 2013, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2013
- 2009
- 2008
- 2005
- 2003
- 2002
- 2001
- 1999
- 1997
- 1995
- 1994
Top applicants under product code MND
Adverse events under product code MND
product code MND- Death
- 6
- Injury
- 255
- Malfunction
- 4,495
- Total
- 4,756
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MND
- K132535 — AUTOBAND LIGATOR
- K083556 — MODIFICATION TO AUTO-BAND LIGATOR
- K081142 — AUTO-BAND LIGATOR
- K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
- K031236 — AUTO-BAND LIGATOR
- K033245 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
- K022434 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
- K013066 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
- K001744 — OLYMPUS ENDOSCOPIC LIGATION DEVICE
- K990864 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
- K984255 — OLYMPUS HX-20 SERIES LIGATING DEVICE
- K964661 — HX-20/21-1 ENDOSCOPIC LIGATOR
- K971137 — BARD RAPIDFIRE MULTIPLE BAND LIGATOR
- K944220 — WILSON COOK MULTIPLE BAND LIGATOR
- K940661 — STIEGMANN-GOFF ENDOSCOPIC LIGATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.