510(k) K212296
K212296 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2". The FDA issued a decision of Substantially Equivalent on Aug 19, 2021. The device falls under product code FDS (Gastroscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Fujifilm Corporation has 69 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2021
- Date Received
- Jul 22, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastroscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To examine or perform procedures in the stomach. 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).