Identity
- Trade Name
- ILLUMISITE FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- Bronchoscope Adapter for use with Olympus bronchoscopes FDA UDI
- Model / Reference
- ILS-2000-PK FDA UDI
- Description
- Bronchoscope Adapter for use with Olympus bronchoscopes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521723962 FDA UDI
- 510(k) Number
- K191394 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope working-channel valve, single-use
Illumisite by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope working-channel valve, single-use.
- Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps — CenterPoint Systems LLC · Class II
- Disposable Biopsy Valve — Micro-tech Usa · Class II
- CONMED CLEARGUARD — Conmed Corporation · Class II
- BioShield — US Endoscopy · Class II
- SINGLE USE BIOPSY VALVE (Sterile) — Olympus Medical Systems Corporation · Class II
- BioGuard — US Endoscopy · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- BullDog® — Diversatek Healthcare · Class II
Cleared under the same submission
K191394 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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 8ce6c91b-c281-481f-8ac7-b550eabe672c 36 fields · synced May 30, 2026