510(k) K771815
K771815 is an FDA 510(k) premarket notification submitted by Dynatech Cryomedical Co. for the device "SIGMOSCOPE". The FDA issued a decision of Substantially Equivalent on October 7, 1977. The device falls under product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Dynatech Cryomedical Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 1977
- Date Received
- September 27, 1977
- 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