← Back to catalogue

Inspire

FDA UDI

Class III (US FDA UDI)

by Inspire Medical Systems

Identity

Trade Name
Inspire FDA UDI
Generic Name
Implantable sleep apnoea treatment system, respiration-sensing FDA UDI
Device Name
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG). FDA UDI
Model / Reference
900-013-003 FDA UDI
Description
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG). FDA UDI

Identifiers

Catalog Number
4340 FDA UDI
Primary DI / UDI-DI
10810098650295 FDA UDI
PMA Number
P130008 FDA UDI
FDA Product Code
MNQ FDA UDI
GMDN Term
Implantable sleep apnoea treatment system, respiration-sensing FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Implantable sleep apnoea treatment system, respiration-sensing

Inspire by Inspire Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable sleep apnoea treatment system, respiration-sensing.

Cleared under the same submission

P130008 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
Inspire Medical Systems

Sources (1)

  • FDA UDI b6ec187c-5758-4465-b4e8-fa1013bcea82 35 fields · synced Jun 8, 2026