510(k) K102544
K102544 is an FDA 510(k) premarket notification submitted by Smith & Nephew Inc., Endoscopy Div. for the device "SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY". The FDA issued a decision of Substantially Equivalent on January 5, 2011. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Smith & Nephew Inc., Endoscopy Div. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2011
- Date Received
- September 3, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type