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NeuGuide™

FDA UDI

Class II (US FDA UDI)

by Femselect Ltd

Identity

Trade Name
NeuGuide™ FDA UDI
Generic Name
Ligament graft, synthetic polymer FDA UDI
Device Name
The NeuGuide™ is a single use trans-vaginal device for the repair of pelvic organ prolapse (POP) by anchoring sutures to ligaments of the pelvic floor. FDA UDI
Model / Reference
FG0001 FDA UDI
Description
The NeuGuide™ is a single use trans-vaginal device for the repair of pelvic organ prolapse (POP) by anchoring sutures to ligaments of the pelvic floor. FDA UDI

Identifiers

Catalog Number
FG0001 FDA UDI
Primary DI / UDI-DI
07290017082004 FDA UDI
510(k) Number
K160569 FDA UDI
FDA Product Code
PBQ FDA UDI
GMDN Term
Ligament graft, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Ligament graft, synthetic polymer

NeuGuide™ by Femselect Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ligament graft, synthetic polymer.

Cleared under the same submission

K160569 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Femselect Ltd

Sources (1)

  • FDA UDI 7ad95d8f-1630-4f2c-8e47-85c930793729 37 fields · synced Jun 6, 2026