PENTAX Medical Video Upper GI Scopes EG17-J10
FDA 510(k) clearance K210177 · decided 2021-10-20
Clearance details
- K-number
- K210177
- Device name
- PENTAX Medical Video Upper GI Scopes EG17-J10
- Applicant
- Pentax of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-22
- Decision date
- 2021-10-20
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.