OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET— 510(k) K072937
Substantially EquivalentOlsen Medical
FDA 510(k) clearance K072937 for OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, Substantially Equivalent on 2007-12-28. Applicant: Olsen Medical. Device class: 2.
Clearance details
- Applicant
- Olsen Medical
- 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
- Traditional
- Location
- Louisville, KY, US
Recent devices under product code GEI
view all- K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
More 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
- K080187 — OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
- 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.