Strong Grasper Ø 5 mm x 310 mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref X0007011Model Senhance Surgical Instruments

by Asensus Surgical Italia S.r.l.

Identity

Trade Name: Strong Grasper Ø 5 mm x 310 mm EUDAMED
Senhance FDA UDI
Generic Name: Robotic surgical forceps, reusable FDA UDI
Device Name: Strong Grasper FDA UDI
Model / Reference: Senhance Surgical Instruments EUDAMED
X0007011 EUDAMEDFDA UDI
Description: Strong Grasper FDA UDI

Identifiers

Catalog Number: 200-11038 FDA UDI
Primary DI / UDI-DI: 00815440020064 EUDAMEDFDA UDI
Basic UDI-DI: 081544002TD005UM EUDAMED
Direct Marketing DI: 00815440020064 EUDAMED
510(k) Number: K171120 FDA UDI
FDA Product Code: NAY FDA UDI
EMDN Code: L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term: Robotic surgical forceps, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Market of Registration: Lithuania EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 310 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI

Category: Robotic surgical forceps, reusable

Strong Grasper Ø 5 mm x 310 mm by Asensus Surgical Italia S.r.l. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical forceps, reusable.

EndoWrist — Intuitive Surgical, Inc. · Class II
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EndoWrist — Intuitive Surgical, Inc. · Class II
Single-Site — Intuitive Surgical, Inc. · Class II
EndoWrist — Intuitive Surgical, Inc. · Class II
Toumai — Shanghai MicroPort MedBot (Group) Co., Ltd. · Class IIb
EndoWrist;daVinci Si — Intuitive Surgical, Inc. · Class II
EndoWrist — Intuitive Surgical, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	081544002TD005UM	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

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

Sources (2)

EUDAMED d8a3a8f9-9572-4139-91e8-81dd3e58282f 61 fields · synced Jun 19, 2026
FDA UDI 20a9d46b-da1b-40b7-a0fb-7c92c18408ae 36 fields · synced May 30, 2026