Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Endoscopic light filter, reusable FDA UDI
- Device Name
- Light Guide Adapter, M3 Gold (Wolf) FDA UDI
- Model / Reference
- 98-0759 FDA UDI
- Description
- Light Guide Adapter, M3 Gold (Wolf) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925008809 FDA UDI
- 510(k) Number
- K911053 FDA UDI
- FDA Product Code
- FFS FDA UDI
- GMDN Term
- Endoscopic light filter, reusable 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic light filter, reusable
Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light filter, reusable.
- Universal Filter — SBI PHARMACEUTICALS CO., LTD. · Class I
Cleared under the same submission
K911053 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI c8c0eed7-7c27-4eec-96d2-d40677396210 34 fields · synced May 30, 2026