Identity
- Trade Name
- MurphyScope FDA UDI
- Generic Name
- Flexible fibreoptic intracranial/spinal endoscope FDA UDI
- Device Name
- MURPHYSCOPE 2125-164 MALLE 5 STIP L FDA UDI
- Model / Reference
- 2125-164 FDA UDI
- Description
- MURPHYSCOPE 2125-164 MALLE 5 STIP L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169103542 FDA UDI
- 510(k) Number
- K010341 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Flexible fibreoptic intracranial/spinal endoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 15.0 Centimeter FDA UDI
Category: Flexible fibreoptic intracranial/spinal endoscope
MurphyScope by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic intracranial/spinal endoscope.
- Flex-X — Karl Storz GmbH & Co. KG · Class II
- ClarusScope — CLARUS MEDICAL, LLC · Class II
- MurphyScope — Medtronic PS Medical · Class II
- MurphyScope — Medtronic PS Medical · Class II
- MurphyScope — Medtronic PS Medical · Class II
- MurphyScope — Medtronic PS Medical · Class II
- NeuroPEN — Medtronic PS Medical · Class II
- MurphyScope — Medtronic PS Medical · Class II
Cleared under the same submission
K010341 also covers:
- Endoscope ACMI Light Cable Adapter — Medtronic PS Medical
- Endoscope Olympus Light Cable Adapter — Medtronic PS Medical
- Endoscope Olympus Light Cable Adapter — Medtronic PS Medical
- Endoscope Storz Light Cable Adapter — Medtronic PS Medical
- Endoscope Universal Light Cable — Medtronic PS Medical
- MurphyScope — Medtronic PS Medical
- MurphyScope — Medtronic PS Medical
- MurphyScope — Medtronic PS Medical
- MurphyScope — Medtronic PS Medical
- MurphyScope — Medtronic PS Medical
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic PS Medical
Sources (1)
- FDA UDI e93ac70b-d1a1-4a6c-9a49-5ef7ee2e7be9 37 fields · synced Jun 8, 2026