510(k) K201934
K201934 is an FDA 510(k) premarket notification submitted by Surgimatix, Inc. for the device "Surgimatix Absorbable Fixation System". The FDA issued a decision of Substantially Equivalent on October 1, 2021. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Surgimatix, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2021
- Date Received
- July 13, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type