OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS— 510(k) K080187
Substantially EquivalentOlsen Medical
FDA 510(k) clearance K080187 for OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS, Substantially Equivalent on 2008-05-09. Applicant: Olsen Medical. Device class: 2.
Clearance details
- Applicant
- Olsen Medical
- 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
- Louisville, KY, US
Recent devices under product code GEI
view allMore clearances from Olsen Medical
view all- K130669 — SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS
- K111262 — ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
- K072937 — OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
- K042073 — OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
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 →
Recalls naming K080187
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 K080187.
Data sourced from openFDA. This site is unofficial and independent of the FDA.