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Athena Surgical RMUS System

FDA UDI

Class II (US FDA UDI)

by Athena Surgical

Identity

Trade Name
Athena Surgical RMUS System FDA UDI
Generic Name
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Device Name
Instrument Handle FDA UDI
Model / Reference
9003 FDA UDI
Description
Instrument Handle FDA UDI

Identifiers

Primary DI / UDI-DI
00860003619803 FDA UDI
510(k) Number
K210087 FDA UDI
FDA Product Code
OTN FDA UDI
GMDN Term
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Athena Surgical RMUS System by Athena Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Female stress urinary incontinence surgical mesh-sling, synthetic polymer.

Cleared under the same submission

K210087 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Athena Surgical

Sources (1)

  • FDA UDI 55978725-7824-4d65-a9a6-06e7bee745e6 34 fields · synced May 30, 2026