510(k) K193558
K193558 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "HEALICOIL Knotless Suture Anchors". The FDA issued a decision of Substantially Equivalent on Mar 18, 2020. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 18, 2020
- Date Received
- Dec 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)