OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER— 510(k) K932668
Substantially EquivalentSynergetics, Inc.
FDA 510(k) clearance K932668 for OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER, Substantially Equivalent on 1994-02-23. Applicant: Synergetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Synergetics, Inc.
- Product code
- Code HQE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterfield, MI, US
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Adverse events under product code HQE
product code HQE- Injury
- 156
- Malfunction
- 565
- Total
- 721
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.