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Archimedies Access Kit with Syringe

FDA UDIEUDAMED

Class II (US FDA UDI)

by Broncus Medical Inc.

Identity

Trade Name
Archimedies Access Kit with Syringe FDA UDI
Generic Name
Lung biopsy procedure kit FDA UDI
Device Name
A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. FDA UDI
Model / Reference
12196-09 FDA UDI
Description
A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. FDA UDI

Identifiers

Catalog Number
10009-09 FDA UDI
Primary DI / UDI-DI
00856571007234 FDA UDI
510(k) Number
K131234 FDA UDI
FDA Product Code
EOQ FDA UDI
GMDN Term
Lung biopsy procedure kit 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

No

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

Category: Lung biopsy procedure kit

Archimedies Access Kit with Syringe by Broncus Medical Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Lung biopsy procedure kit.

Cleared under the same submission

K131234 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Broncus Medical Inc.

Sources (2)

  • FDA UDI 093a6a0b-4e29-4a55-bd42-4a8492690034 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026