510(k) K263073
K263073 is an FDA 510(k) premarket notification submitted by Riverpoint Medical, LLC for the device "Fast Absorbing PGLA". The FDA issued a decision of Substantially Equivalent on Sep 29, 2026. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Riverpoint Medical, LLC has 39 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2026
- Date Received
- Sep 1, 2026
- Clearance Type
- Special
- 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
- 510(k)