← Back to catalogue

Senhance Ultrasonic

FDA UDI

Class II (US FDA UDI)

by Asensus Surgical, Inc.

Identity

Trade Name
Senhance Ultrasonic FDA UDI
Generic Name
Foot-switch, pneumatic FDA UDI
Device Name
Senhance Ultrasonic Footswitch FDA UDI
Model / Reference
X9007641 FDA UDI
Description
Senhance Ultrasonic Footswitch FDA UDI

Identifiers

Catalog Number
300-01012 FDA UDI
Primary DI / UDI-DI
00815440021597 FDA UDI
510(k) Number
K182421 FDA UDI
FDA Product Code
NAY FDA UDI
GMDN Term
Foot-switch, pneumatic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Category: Foot-switch, pneumatic

Senhance Ultrasonic by Asensus Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Foot-switch, pneumatic.

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
Asensus Surgical, Inc.

Sources (1)

  • FDA UDI c7a58997-5dee-4ab0-af0d-6ccf9baf2792 35 fields · synced Sep 18, 2026