Video Processor Epk-I5010-Us
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04961333231942 | Date16 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122470 | Date10 Apr 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 8 Nov 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Video Processor
- Generic name
- Endoscopic video image processing unit
- Model / reference
- EPK-I5010-US
- Primary DI / UDI-DI
- 04961333231942
- 510(k) Number
- FDA product code
- PEA
- GMDN term
- Endoscopic video image processing unit
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Other devices from PENTAX of America Inc.
Properties
Other properties (13)
- Supplied sterile: No
- Sterilise before use: No
- Single use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Lot / batch number: No
- Expiration date: No
- Manufacturing date: No