510(k) K943697
K943697 is an FDA 510(k) premarket notification submitted by Karl Storz Endoskop GmbH for the device "TROCARS,CANNULAE,SHEATHS,OBTURATORS". The FDA issued a decision of Substantially Equivalent on September 14, 1994. The device falls under product code ODB (Endoscopic Contamination Prevention Sheath), a Class II device regulated under 21 CFR 876.1500. Karl Storz Endoskop GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1994
- Date Received
- July 29, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Contamination Prevention Sheath
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.