Identity
- Trade Name
- UreTron Rigid Scope Connector FDA UDI
- Generic Name
- Endoscope assembly adaptor FDA UDI
- Device Name
- UreTron Rigid Scope connector FDA UDI
- Model / Reference
- URT-CK-RW FDA UDI
- Description
- UreTron Rigid Scope connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854732006249 FDA UDI
- 510(k) Number
- K160198 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- Endoscope assembly adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Endoscope assembly adaptor
UreTron Rigid Scope Connector by Ultratellege USA Co. LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope assembly adaptor.
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- Reducer — SOPRO-COMEG GmbH · Class II
- STORZ — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K160198 also covers:
- UreTron Cleaning Rod — Ultratellege USA Co. LTD.
- UreTron Flex Hand Piece — Ultratellege USA Co. LTD.
- UreTron Flexible Sterile Probe 0.8 x 1200 mm — Ultratellege USA Co. LTD.
- UreTron Flexible Sterile Probe 0.8 x 600 mm — Ultratellege USA Co. LTD.
- UreTron Footswitch Dual Connector — Ultratellege USA Co. LTD.
- UreTron Footswitch Single Connector — Ultratellege USA Co. LTD.
- UreTron Generator — Ultratellege USA Co. LTD.
- UreTron Power Cord — Ultratellege USA Co. LTD.
- UreTron Rigid Hand Piece — Ultratellege USA Co. LTD.
- UreTron Rigid Sterile Probe 3.1 x 370mm — Ultratellege USA Co. LTD.
- UreTron Rigid Sterile Probe 3.1 x 430 mm — Ultratellege USA Co. LTD.
- UreTron Rigid Sterile Probe 3.5 x 370 mm — Ultratellege USA Co. LTD.
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 |
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Manufacturer
- Manufacturer
- Ultratellege USA Co. LTD.
Sources (1)
- FDA UDI de0e4ae9-5715-4ec9-a189-e4110b4484d6 34 fields · synced May 31, 2026