SURGIN GENISIS HANDPIECE— 510(k) K954238
Substantially EquivalentSurgin Surgical Instrumentation, Inc.
FDA 510(k) clearance K954238 for SURGIN GENISIS HANDPIECE, Substantially Equivalent on 1995-12-08. Applicant: Surgin Surgical Instrumentation, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgin Surgical Instrumentation, Inc.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temple City, CA, US
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More clearances from Surgin Surgical Instrumentation, Inc.
view all- K082110 — DUAL SYRINGE HOLDER
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- K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
- K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
- K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.