SHURE GRIP TYING FORCEPS— 510(k) K844129
Substantially EquivalentMentor O & O, Inc.
FDA 510(k) clearance K844129 for SHURE GRIP TYING FORCEPS, Substantially Equivalent on 1984-11-21. Applicant: Mentor O & O, Inc..
Clearance details
- Applicant
- Mentor O & O, Inc.
- Product code
- Code HNR
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hingham, MA, US
Adverse events under product code HNR
product code HNR- Malfunction
- 497
- Other
- 1
- Total
- 498
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.