510(k) K093557
K093557 is an FDA 510(k) premarket notification submitted by Clearcount Medical Solutions for the device "SMARTWAND-DTX". The FDA issued a decision of Substantially Equivalent on December 18, 2009. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740. Clearcount Medical Solutions has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2009
- Date Received
- November 16, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Counter, Sponge, Surgical
- Device Class
- Class I
- Regulation Number
- 880.2740
- Review Panel
- SU
- Submission Type