510(k) K162198
K162198 is an FDA 510(k) premarket notification submitted by Parcus Medical, LLC for the device "GFS Ultimate". The FDA issued a decision of Substantially Equivalent on Nov 18, 2016. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Parcus Medical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2016
- Date Received
- Aug 5, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type