Andorate Universal Endoscope Tip Guard
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Universal Endoscope Tip Guard EUDAMEDandorate® Universal Endoscope Tip Guard FDA UDI
- Generic Name
- Surgical instrument guard, single-use, sterile FDA UDI
- Device Name
- Tip Guard EUDAMED
- Model / Reference
- GAR107-S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106952892 EUDAMEDFDA UDI
- Basic UDI-DI
- 489710695GAR107-SRV EUDAMED
- 510(k) Number
- K202838 FDA 510(k)
- FDA Product Code
- OCU FDA 510(k)FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Surgical instrument guard, single-use, sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)FDA UDI
- Market of Registration
- Ireland EUDAMED
- 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
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Andorate Universal Endoscope Tip Guard is classified as an Endoscopic Storage Cover (Product Code: OCU) under FDA regulation 876.1500. This device is designed to protect the tip of endoscopes during transport and storage, safeguarding against moisture ingress and physical damage while maintaining hygiene standards. It is intended for use in gastroenterology and urology procedures, where endoscope integrity is critical to procedural safety and infection control. The device adheres softly to the scope, minimising contact and ensuring secure attachment throughout handling.
The Andorate Universal Endoscope Tip Guard is supplied as a single-use device, ensuring sterility and reducing cross-contamination risks. It is compatible with various endoscope models and is intended for use in clinical settings, including operating rooms, endoscopy suites, and storage areas. The device is authorised under FDA 510K clearance (K202838) and MDR compliance, adhering to regulatory standards for medical devices in endoscopy. Storage instructions specify protection from direct sunlight and extreme temperatures, and it must be discarded after a single use to maintain sterility and performance.
Frequently asked questions
What types of endoscopes is the Andorate Universal Endoscope Tip Guard compatible with?
The Andorate Universal Endoscope Tip Guard is designed to be compatible with a wide range of endoscope models, as indicated by its universal design. It is specifically intended for use in gastroenterology and urology procedures, ensuring protection for the tip of various scopes during transport and storage. The device’s soft adhesion mechanism minimizes contact while securing the attachment, making it versatile for different scope types.
Is the Andorate Universal Endoscope Tip Guard reusable, or is it meant for single-use only?
The Andorate Universal Endoscope Tip Guard is explicitly supplied as a single-use device. This design choice ensures sterility is maintained throughout its intended use, reducing the risk of cross-contamination between patients or procedures. After use, it must be discarded to comply with hygiene standards and preserve the device’s performance.
How should the Andorate Universal Endoscope Tip Guard be stored to ensure its effectiveness?
The device should be stored in a location protected from direct sunlight and extreme temperatures to prevent degradation. Since it is single-use and sterile, it must remain unopened until use. Proper storage conditions help maintain the material integrity and sterility required for safe and effective use in clinical settings like endoscopy suites or operating rooms.
What regulatory pathways does the Andorate Universal Endoscope Tip Guard follow, and where is it authorized?
The Andorate Universal Endoscope Tip Guard is authorized under FDA 510K clearance (K202838) and MDR compliance, confirming its adherence to regulatory standards for medical devices in endoscopy. It is classified under FDA Product Code OCU (Endoscopic Storage Cover) and is intended for use in gastroenterology and urology settings, as reflected in its advisory committee designation (GU).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Andorate Tip Guard | Endocope Protection | Tip Guard for endoscopy | GA ..., Endoscopy Medical Devices | Andorate | GI endoscopy | GA Health, GAR107-S Endoscope Tip Guard | Endo Transport & Storage - GA Health, GAR107 Endoscope Tip Guard | Endo Transport & Storage - GA Health
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202838 | Class II | Active |
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Manufacturer
- Manufacturer
- Ga Health Company Limited
Sources (3)
- FDA 510(k) K202838 24 fields · synced Sep 20, 2026
- FDA UDI 21bf3cac-894a-42a5-842d-40172f73f5d0 32 fields · synced May 30, 2026
- EUDAMED f7ef00f2-a896-45b8-adbd-3af8a76000e5 61 fields · synced Jul 10, 2026