Identity
- Trade Name
- Endogator Kit FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Endogator Kit includes Endogator Irrigation Tubing compatible with Boston Scientific Endostat II, Olympus OFP and Endo Stratus Irrigation Pump units, and Endo ENDO SMARTCAP Rinse and insufflation Tubing for PENTAX GI Endoscopes. FDA UDI
- Model / Reference
- 4005471 FDA UDI
- Description
- Endogator Kit includes Endogator Irrigation Tubing compatible with Boston Scientific Endostat II, Olympus OFP and Endo Stratus Irrigation Pump units, and Endo ENDO SMARTCAP Rinse and insufflation Tubing for PENTAX GI Endoscopes. FDA UDI
Identifiers
- Catalog Number
- 4005471 FDA UDI
- Primary DI / UDI-DI
- 40677964028104 FDA UDI
- 510(k) Number
- K102855 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- 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
Yes
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
No
FDA UDI
Category: Surgical irrigation tubing set, single-use
Endogator Kit by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation tubing set, single-use.
- SuperFlow Tubing Set — ARMM INC. · Class II
- Irrigation Set — B. BRAUN MEDICAL INC. · Class II
- IPC™ Visao® — MEDTRONIC XOMED, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- CODMAN® — Integra LifeSciences Switzerland Sàrl · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Endo-Flo — Davol Inc. · Class II
- AESCULAP — AESCULAP, INC. · Class II
Cleared under the same submission
K102855 also covers:
- ENDOGATOR — MEDIVATORS INC.
- ENDOGATOR Hybrid Irrigation Tubing — MEDIVATORS INC.
- ENDOGATOR Hybrid Irrigation Tubing — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
- ENDOGATOR Kit — MEDIVATORS INC.
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
- Medivators Inc.
Sources (1)
- FDA UDI 9f24d90a-e088-4385-9be4-1cef1ecd969e 36 fields · synced May 30, 2026