510(k) K171494
K171494 is an FDA 510(k) premarket notification submitted by Gordian Surgical, Ltd. for the device "TroClose1200, TroClose1200 Cannula". The FDA issued a decision of Substantially Equivalent on June 15, 2017. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Gordian Surgical, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2017
- Date Received
- May 22, 2017
- 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