Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- Telescope ULTRA IR, 5.4 mm, 30° FDA UDI
- Model / Reference
- WAIR530A FDA UDI
- Description
- Telescope ULTRA IR, 5.4 mm, 30° FDA UDI
Identifiers
- Catalog Number
- WAIR530A FDA UDI
- Primary DI / UDI-DI
- 04042761086189 FDA UDI
- 510(k) Number
- K200542 FDA UDI
- FDA Product Code
- GCJ FDA UDIHET FDA UDI
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1720 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
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical laparoscope
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical laparoscope.
- Laparoscope — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- MEDIVISION — MEDIVISION, INC. · Class II
- Laparoscope — SOPRO-COMEG GmbH · Class II
- CONMED — Conmed Corporation · Class II
- ELMED — ELMED INCORPORATED · Class II
Cleared under the same submission
K200542 also covers:
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD — Olympus Medical Systems Corporation
- HD 3CMOS CAMERA HEAD — Olympus Medical Systems Corporation
- VISERA ELITE II VIDEO SYSTEM CENTER — Olympus Medical Systems Corporation
- VISERA ELITE II XENON LIGHT SOURCE — Olympus Medical Systems Corporation
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
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 Winter & Ibe GmbH
Sources (1)
- FDA UDI c74e29f7-bded-41d5-beb4-177d89cbce80 36 fields · synced Jun 8, 2026