510(k) K951104
K951104 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "ENDOBOOT". The FDA issued a decision of Substantially Equivalent on April 6, 1995. The device falls under product code OCU (Endoscopic Storage Cover), a Class II device regulated under 21 CFR 876.1500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1995
- Date Received
- March 10, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Storage Cover
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.