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Force Feedback

FDA UDI

Class II (US FDA UDI)

by Intuitive Surgical, Inc.

Identity

Trade Name
Force Feedback FDA UDI
Generic Name
Robotic surgical needle holder, reusable FDA UDI
Device Name
Force Feedback Mega SutureCut Needle Driver FDA UDI
Model / Reference
475309 FDA UDI
Description
Force Feedback Mega SutureCut Needle Driver FDA UDI

Identifiers

Primary DI / UDI-DI
00886874125458 FDA UDI
510(k) Number
K241284 FDA UDI
FDA Product Code
NAY FDA UDI
GMDN Term
Robotic surgical needle holder, reusable 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 8 Millimeter FDA UDI

Category: Robotic surgical needle holder, reusable

Force Feedback by Intuitive Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical needle holder, reusable.

Cleared under the same submission

K241284 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intuitive Surgical, Inc.

Sources (1)

  • FDA UDI 972895dc-dc0c-40a4-8de1-cc7da863e9ad 35 fields · synced Jun 9, 2026