UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES— 510(k) K132224
Substantially EquivalentUnimed Surgical Products, Inc.
FDA 510(k) clearance K132224 for UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES, Substantially Equivalent on 2013-10-08. Applicant: Unimed Surgical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Unimed Surgical Products, 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
- Traditional
- Location
- Largo, FL, US
Recent devices under product code GEI
view allMore clearances from Unimed Surgical Products, Inc.
view all- K993647 — UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
- K970066 — UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
- K963338 — UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
- K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
- K944450 — SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
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.