510(k) K221527
K221527 is an FDA 510(k) premarket notification submitted by Origami Surgical Inc . for the device "StitchKit". The FDA issued a decision of Substantially Equivalent on February 14, 2023. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Origami Surgical Inc . has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2023
- Date Received
- May 26, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type