PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE— 510(k) K102709
Substantially EquivalentPeak Surgical, Inc.
FDA 510(k) clearance K102709 for PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE, Substantially Equivalent on 2010-12-17. Applicant: Peak Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Peak Surgical, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palo Alto, CA, US
Recent devices under product code GEI
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view all- K103775 — PEAK SUCTION COAGULATOR
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- K093695 — PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
- K083415 — PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
- K082786 — PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.