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Xpan Universal Trocar System

FDA UDI

Class II (US FDA UDI)

by Xpan, Inc.

Identity

Trade Name
Xpan Universal Trocar System FDA UDI
Generic Name
Laparoscopic access cannula, single-use FDA UDI
Device Name
Xpan 12mm Cannula with Obturator, Standard Length (x1) FDA UDI
Model / Reference
XP1077-01 FDA UDI
Description
Xpan 12mm Cannula with Obturator, Standard Length (x1) FDA UDI

Identifiers

Primary DI / UDI-DI
00860007212239 FDA UDI
510(k) Number
K223562 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic access cannula, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Laparoscopic access cannula, single-useLaparoscopic trocar blade, single-use

Xpan Universal Trocar System by Xpan, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic trocar blade, single-use.

Cleared under the same submission

K223562 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xpan, Inc.

Sources (1)

  • FDA UDI da3943c6-5d61-4cdd-a237-5111f0ef45fa 34 fields · synced Jun 1, 2026