STIEGMANN-GOFF ENDOSCOPIC LIGATOR— 510(k) K940661
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K940661 for STIEGMANN-GOFF ENDOSCOPIC LIGATOR, Substantially Equivalent on 1994-11-28. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code MND
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tewksbury, MA, US
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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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.