CUTO(TM) TISSUE MORCELLATION SYSTEM— 510(k) K932700
Substantially EquivalentLinvatec Corp.
FDA 510(k) clearance K932700 for CUTO(TM) TISSUE MORCELLATION SYSTEM, Substantially Equivalent on 1993-10-15. Applicant: Linvatec Corp.. Device class: 1.
Clearance details
- Applicant
- Linvatec Corp.
- Product code
- Code GEY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
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Adverse events under product code GEY
product code GEY- Malfunction
- 7,488
- Total
- 7,488
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.