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Sureform

FDA UDI

Class II (US FDA UDI)

by Intuitive Surgical, Inc.

Identity

Trade Name
Sureform FDA UDI
Generic Name
Surgical staple loading unit, non-cutting FDA UDI
Device Name
8mm Stapler FDA UDI
Model / Reference
48230W FDA UDI
Description
8mm Stapler FDA UDI

Identifiers

Primary DI / UDI-DI
00886874121924 FDA UDI
510(k) Number
K211997 FDA UDI
FDA Product Code
NAY FDA UDI
GDW FDA UDI
GMDN Term
Surgical staple loading unit, non-cutting FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Depth — 30 Millimeter FDA UDI

Category: Surgical staple loading unit, non-cutting

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

Similar devices

Also classified as Surgical staple loading unit, non-cutting.

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 3c30b490-75f6-42c5-9e8a-3d4ceaee9e93 35 fields · synced Jun 9, 2026