Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027641465

FEI Number

3027641465

Entity Name

BIBB INSTRUMENTS AB

City/State/Country

Lund Skane, SE

Establishment Address

Medicon Village, SE-223 81, Lund Skane 223 81, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bibb Instruments AB (Owner Number: 10088463)

Owner / Operator Contact Address

Medicon Village, SE-223 81, Lund, SE-M 223 81, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212423

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2023-07-26

Official Correspondent

Fredrik Lindblad

US Agent Details

David Makanani Business: OMEDtech Email: dmakanani@omedtech.com Phone: (405) 8260713

Related Public Records

Same Entity

Bibb Instruments AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Similar Registrations

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3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US
3010188783	JAPAN GAS COMPANY LIMITED	YOKOHAMA Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027641465. Last updated year: 2026. Please use registration number 3027641465 when referencing this establishment in official correspondence.