Arcpoint

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Arcpoint FDA UDI
Generic Name: General-purpose endoscopic needle, single-use FDA UDI
Device Name: pulmonary needle FDA UDI
Model / Reference: ILS-2100-PN FDA UDI
Description: pulmonary needle FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521723610 FDA UDI
510(k) Number: K163537 FDA UDI
FDA Product Code: EOQ FDA UDI
GMDN Term: General-purpose endoscopic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4680 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

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 21 Gauge FDA UDI
Length — 137 Centimeter FDA UDI
Outer Diameter — 1.9 Millimeter FDA UDI

Category: General-purpose endoscopic needle, single-use

Arcpoint by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose endoscopic needle, single-use.

Single Use Aspiration Needle NA-U201H — Olympus Medical Systems Corporation · Class II
ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Porges Coloplast — Coloplast A/S · Class II
ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Injectra, ScleroTip — Medi-Globe Corporation · Class II
Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
Henry Schein — HENRY SCHEIN, INC. · Class I

Cleared under the same submission

K163537 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI d1020d7e-2970-40c5-a7b4-9c7d280f836d 37 fields · synced May 31, 2026