510(k) K191317
K191317 is an FDA 510(k) premarket notification submitted by Origami Surgical for the device "StitchKit". The FDA issued a decision of Substantially Equivalent on July 12, 2019. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Origami Surgical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2019
- Date Received
- May 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device Class
- Class II
- Regulation Number
- 878.5035
- Review Panel
- SU
- Submission Type