510(k) K023704
K023704 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA SCB ACC CONTROL". The FDA issued a decision of Substantially Equivalent on January 30, 2003. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2003
- Date Received
- November 4, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type