510(k) K050403
K050403 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "SPYGLASS DIRECT VISULATION PROBE". The FDA issued a decision of Substantially Equivalent on March 4, 2005. The device falls under product code ODF (Mini Endoscope, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2005
- Date Received
- February 17, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Mini Endoscope, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).