Identity
- Trade Name
- VIDEO SIGMOIDOSCOPE FDA UDI
- Generic Name
- Flexible video gastroscope, reusable FDA UDI
- Device Name
- VIDEO SIGMOIDOSCOPES (REFURBISHED) FDA UDI
- Model / Reference
- ES-3830K FDA UDI
- Description
- VIDEO SIGMOIDOSCOPES (REFURBISHED) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333232635 FDA UDI
- 510(k) Number
- K951577 FDA UDI
- FDA Product Code
- FAM FDA UDI
- GMDN Term
- Flexible video gastroscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Video Sigmoidoscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K951577 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (1)
- FDA UDI 35ba7133-c451-40c0-a717-97bf10baa685 35 fields · synced May 30, 2026