← Back to catalogue
ReShape Calibration Tubes
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K230131
Identity
- Trade Name
- ReShape Calibration Tubes FDA UDI
- Generic Name
- Gastric calibration tube FDA UDI
- Device Name
- Calibration and Sizing Tube 40 French FDA UDI
- Model / Reference
- B-2040 FDA UDI
- Description
- Calibration and Sizing Tube 40 French FDA UDI
Identifiers
- Catalog Number
- B-2040 FDA UDI
- Primary DI / UDI-DI
- 00850007764272 FDA UDI
- 510(k) Number
- FDA Product Code
- KNT FDA 510(k)FDA UDI
- GMDN Term
- Gastric calibration tube FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)FDA UDI
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
ReShape Calibration Tubes by Reshape Lifesciences — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230131 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reshape Lifesciences
Sources (2)
- FDA 510(k) K230131 24 fields · synced Jun 18, 2026
- FDA UDI f9d94985-d341-4eab-98ba-9a28f0db4862 37 fields · synced May 27, 2026