Identity
- Trade Name
- INTERFACE FOR ESU (FORCE SERIES) FDA UDI
- Generic Name
- Electrical-only medical device connection adaptor, reusable FDA UDI
- Device Name
- INTERFACE FOR ESU (FORCE SERIES) FDA UDI
- Model / Reference
- MAJ-2250 FDA UDI
- Description
- INTERFACE FOR ESU (FORCE SERIES) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170391873 FDA UDI
- 510(k) Number
- K172618 FDA UDI
- FDA Product Code
- GCJ FDA UDIODA FDA UDI
- GMDN Term
- Electrical-only medical device connection adaptor, 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrical-only medical device connection adaptor, reusable
Interface For Esu (force Series) by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection adaptor, reusable.
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- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
Cleared under the same submission
K172618 also covers:
- INTERFACE FOR ESU (VIO SERIES) — Olympus Medical Systems Corporation
- INTERFACE FOR OLYMPUS LINK DEVICE — Olympus Medical Systems Corporation
- MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 — Olympus Medical Systems Corporation
- UCES-4 Upgrade Pack 2 — Olympus Medical Systems Corporation
- UNIVERSAL INTERFACE — Olympus Medical Systems Corporation
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI dc17b507-b283-4972-8c3b-34d2ccd7fb4e 35 fields · synced May 30, 2026