ShinEvac Smoke Evacuation Pencil
FDA 510(k) clearance K213317 · decided 2022-01-28
Clearance details
- K-number
- K213317
- Device name
- ShinEvac Smoke Evacuation Pencil
- Applicant
- Shining World Health Care Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-04
- Decision date
- 2022-01-28
- Days to decision
- 116 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
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.