Identity
- Trade Name
- ANTENNA UNIT FDA UDI
- Generic Name
- Video capsule endoscopy system antenna FDA UDI
- Model / Reference
- MAJ-2031 FDA UDI
Identifiers
- Catalog Number
- N4471840 FDA UDI
- Primary DI / UDI-DI
- 04953170328350 FDA UDI
- 510(k) Number
- K183053 FDA UDI
- FDA Product Code
- NEZ FDA UDI
- GMDN Term
- Video capsule endoscopy system antenna FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1300 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: Video capsule endoscopy system antenna
Antenna Unit by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183053 also covers:
- ANTENNA UNIT HOLDER — Olympus Medical Systems Corporation
- BATTERY PACK — Olympus Medical Systems Corporation
- CAPSULE ACTIVATOR — Olympus Medical Systems Corporation
- CRADLE — Olympus Medical Systems Corporation
- ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET — Olympus Medical Systems Corporation
- ENDOCAPSULE SOFTWARE 10 — Olympus Medical Systems Corporation
- ENDOCAPSULE SOFTWARE 10 LIGHT — Olympus Medical Systems Corporation
- ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE — Olympus Medical Systems Corporation
- LEAD ANTENNA UNIT — Olympus Medical Systems Corporation
- RECORDER HOLDER — 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 9f3c2eb6-4881-422d-8a04-01e75142a4ba 35 fields · synced May 30, 2026