Trocar Introducer For Ltf 5mm Scope Maj-1379

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: TROCAR INTRODUCER FOR LTF 5MM SCOPE MAJ-1379 FDA UDI
Generic Name: Endoscopic-access dilator, reusable FDA UDI
Model / Reference: MAJ-1379 FDA UDI

Identifiers

Catalog Number: N3831940 FDA UDI
Primary DI / UDI-DI: 04953170452031 FDA UDI
510(k) Number: K201832 FDA UDI
FDA Product Code: NWB FDA UDI
GCJ FDA UDI
HET FDA UDI
GMDN Term: Endoscopic-access dilator, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
884.1720 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic-access dilator, reusable

Trocar Introducer For Ltf 5mm Scope Maj-1379 by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic-access dilator, reusable.

Target Endoscopic Instrument — SOLENDOS Inc. · Class I
Simpact Tri-Fin — Life Spine, Inc. · Class II
Percutaneous Nephrostomy Dilator — Well Lead Medical Co., Ltd · Class I
Arthrex® — Arthrex, Inc. · Class I
AVATAR Minimally Invasive Spinal System — Life Spine, Inc. · Class II
iLESSYS® — JOIMAX, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I
TESSYS® — JOIMAX, INC. · Class I

Cleared under the same submission

K201832 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI f680d7bd-ee39-4f33-b9e0-f17462720521 35 fields · synced May 30, 2026