MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
FDA 510(k) clearance K100543 · decided 2010-07-23
Clearance details
- K-number
- K100543
- Device name
- MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
- Applicant
- Medisiss
- Decision
- Substantially Equivalent
- Date received
- 2010-02-25
- Decision date
- 2010-07-23
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue) recall (Z-1548-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2025-04-09 |