SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES— 510(k) K010710
Substantially EquivalentSeedling Enterprises., LLC
FDA 510(k) clearance K010710 for SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES, Substantially Equivalent on 2001-05-18. Applicant: Seedling Enterprises., LLC. Device class: 2.
Clearance details
- Applicant
- Seedling Enterprises., LLC
- Product code
- Product 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
- Traditional
- Location
- Hopkinton, MA, US
Recent devices under product code GEI
view all- K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
More clearances from Seedling Enterprises., LLC
view allAdverse 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.