510(k) K173644
K173644 is an FDA 510(k) premarket notification submitted by Dura Tap, LLC for the device "Gazelle Polypropylene Suture and Delivery Device". The FDA issued a decision of Substantially Equivalent on February 15, 2018. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Dura Tap, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2018
- Date Received
- November 27, 2017
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type