Green OR Reprocessed Aquamantys Bipolar Sealer
FDA 510(k) clearance K211203 · decided 2022-04-07
Clearance details
- K-number
- K211203
- Device name
- Green OR Reprocessed Aquamantys Bipolar Sealer
- Applicant
- Green Or, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-04-22
- Decision date
- 2022-04-07
- Days to decision
- 350 days
- Clearance type
- Traditional
- Product code
- NUJ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Golden Valley, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.