510(k) K090197
K090197 is an FDA 510(k) premarket notification submitted by Pentax Medical Company for the device "EG-3870UTK". The FDA issued a decision of Substantially Equivalent on May 19, 2009. The device falls under product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Pentax Medical Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2009
- Date Received
- January 27, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Ultrasound System, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).