510(k) K921690
K921690 is an FDA 510(k) premarket notification submitted by Vision-Sciences, Inc. for the device "FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 1992. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Vision-Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1992
- Date Received
- April 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sigmoidoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
to examine and perform procedures within the sigmoid (descending) colon