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Ultrasonic Dissector

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref X9007619Model Senhance Ultrasonic Surgical System

by Asensus Surgical Italia S.r.l.

Identity

Trade Name
Ultrasonic Dissector EUDAMED
Senhance Ultrasonic FDA UDI
Generic Name
Soft-tissue ultrasonic robotic surgical instrument, single-use FDA UDI
Device Name
Ultrasonic Dissector EUDAMED
Senhance Ultrasonic Dissector FDA UDI
Model / Reference
Senhance Ultrasonic Surgical System EUDAMED
X9007619 EUDAMEDFDA UDI
Description
Senhance Ultrasonic Dissector FDA UDI

Identifiers

Catalog Number
300-11010 FDA UDI
Primary DI / UDI-DI
00815440021566 EUDAMEDFDA UDI
Basic UDI-DI
081544002TD003AQ6 EUDAMED
Direct Marketing DI
00815440021566 EUDAMED
510(k) Number
K182421 FDA UDI
FDA Product Code
NAY FDA UDI
EMDN Code
K0202010602 LAPAROSCOPIC AND THORACOSCOPIC ULTRASONIC SURGERY DISSECTORS, SINGLE-USE EUDAMED
GMDN Term
Soft-tissue ultrasonic robotic surgical instrument, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Ultrasonic Dissector by Asensus Surgical Italia S.r.l. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Asensus Surgical Italia S.r.l.
EUDAMED SRN
IT-MF-000007964

Sources (3)

  • EUDAMED a81a6fa2-71f2-4ad6-99e3-d198264d237f 61 fields · synced Jul 10, 2026
  • FDA UDI d13a3cc4-a254-4442-bbfc-426f190cecd5 35 fields · synced May 30, 2026
  • FDA 510(k) K254192 1 fields · synced May 29, 2026