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Sureform

FDA UDI

Class II (US FDA UDI)

by Intuitive Surgical, Inc.

Identity

Trade Name
Sureform FDA UDI
Generic Name
Robotic surgical cutting stapler, reusable FDA UDI
Device Name
8mm Stapler FDA UDI
Model / Reference
488530 FDA UDI
Description
8mm Stapler FDA UDI

Identifiers

Primary DI / UDI-DI
00886874121726 FDA UDI
510(k) Number
K211997 FDA UDI
FDA Product Code
GDW FDA UDI
NAY FDA UDI
GMDN Term
Robotic surgical cutting stapler, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4750 FDA UDI
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 8 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Robotic surgical cutting stapler, reusable

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

Similar devices

Also classified as Robotic surgical cutting stapler, reusable.

Cleared under the same submission

K211997 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 cbad4307-a69b-4e83-aa20-61cee714681f 35 fields · synced Jun 9, 2026