StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
FDA 510(k) clearance K173874 · decided 2018-05-04
Clearance details
- K-number
- K173874
- Device name
- StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
- Applicant
- Origami Surgical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-12-21
- Decision date
- 2018-05-04
- Days to decision
- 134 days
- Clearance type
- Traditional
- 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.