510(k) K861017
K861017 is an FDA 510(k) premarket notification submitted by Galenica Enterprises, Inc. for the device "GALENICA'S DISPOSABLE ANOSCOPES". The FDA issued a decision of Substantially Equivalent on June 13, 1986. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Galenica Enterprises, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1986
- Date Received
- March 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anoscope And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine and perform procedures within the anus and rectum.