510(k) K840722
K840722 is an FDA 510(k) premarket notification submitted by Trimedyne, Inc. for the device "ENTEROSCOPE". The FDA issued a decision of Substantially Equivalent on June 7, 1984. The device falls under product code FDA (Enteroscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Trimedyne, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 1984
- Date Received
- February 17, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enteroscope And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To provide visualization and perform various procedures within the small intestine. 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).