510(k) K881469
K881469 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL". The FDA issued a decision of Substantially Equivalent on Sep 12, 1988. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 12, 1988
- Date Received
- Apr 7, 1988
- 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
- 510(k)
To examine and perform procedures within the anus and rectum.