StitchKit
FDA 510(k) clearance K211792 · decided 2021-07-16
Clearance details
- K-number
- K211792
- Device name
- StitchKit
- Applicant
- Origami Surgical Inc .
- Decision
- Substantially Equivalent
- Date received
- 2021-06-10
- Decision date
- 2021-07-16
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Madison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.