UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F— 510(k) K993647
Substantially EquivalentUnimed Surgical Products, Inc.
FDA 510(k) clearance K993647 for UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F, Substantially Equivalent on 1999-11-16. 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
- Special
- Location
- Largo, FL, US
Recent devices under product code GEI
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- 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.