EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS— 510(k) K031081
Substantially EquivalentGyrus Medical, Inc.
FDA 510(k) clearance K031081 for EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS, Substantially Equivalent on 2003-05-21. Applicant: Gyrus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyrus Medical, Inc.
- 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
- Special
- Location
- Maple Grove, MN, US
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- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
More clearances from Gyrus Medical, Inc.
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 →
Recalls naming K031081
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031081.
Data sourced from openFDA. This site is unofficial and independent of the FDA.