Standard Trocar

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K200517

by Standard Bariatrics

Identity

Trade Name: Standard Trocar FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Model / Reference: ST19-1 FDA UDI

Identifiers

Catalog Number: ST19 FDA UDI
Primary DI / UDI-DI: 00851677007041 FDA UDI
510(k) Number: K200517 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

FDA UDI

Contains Latex

FDA UDI

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laparoscopic access cannula, single-use

Standard Trocar by Standard Bariatrics — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K200517	Class II	Active

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Manufacturer

Manufacturer: Standard Bariatrics

Sources (2)

FDA UDI e225376e-2d0a-47b6-b263-861c4e5aa802 58 fields · synced Jun 18, 2026
FDA 510(k) K200517 1 fields · synced Jun 4, 2026