SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES— 510(k) K010710

Name: FDA 510(k) clearance K010710
Creator: U.S. Food and Drug Administration
Published: 2001-05-18

Substantially Equivalent

Seedling 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: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2001-03-09
Decision date: 2001-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkinton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

More clearances from Seedling Enterprises., LLC

view all

K012033 — MULTIFUNCTION ENDOSCOPIC INSTRUMENT2001-09-20
K002841 — COOL-TEC ELECTRODES2000-12-08
K001723 — COOL-TEC ELECTRODES2000-07-19

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, 2020-01-01 through 2026-04-23. 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.