510(k) K121604
K121604 is an FDA 510(k) premarket notification submitted by Obp Corporation for the device "ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT". The FDA issued a decision of Substantially Equivalent on July 27, 2012. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Obp Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2012
- Date Received
- June 1, 2012
- 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.