← Back to catalogue

NeuroPEN

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
NeuroPEN FDA UDI
Generic Name
Flexible fibreoptic intracranial/spinal endoscope FDA UDI
Device Name
NEUROPEN 27769 W/NO EPOXY OVER END FDA UDI
Model / Reference
27769 FDA UDI
Description
NEUROPEN 27769 W/NO EPOXY OVER END FDA UDI

Identifiers

Primary DI / UDI-DI
00721902879784 FDA UDI
510(k) Number
K003914 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

Category: Flexible fibreoptic intracranial/spinal endoscope

NeuroPEN 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.

Cleared under the same submission

K003914 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic PS Medical

Sources (1)

  • FDA UDI b2282159-45cb-4dbe-9a69-ad0104fc25e2 36 fields · synced Jun 8, 2026