Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005675811

FEI Number

3005675811

Entity Name

QSUM BIOPSY DISPOSABLES LLC

City/State/Country

Pequot Lakes, MN, US

Establishment Address

8624 County Road 1 Sw, Pequot Lakes, MN 56472, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

QSUM BIOPSY DISPOSABLES LLC (Owner Number: 9085466)

Owner / Operator Contact Address

8624 County Rd 1 SW, --, Pequot Lakes, MN 56472, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

#11 MRI Disposable Scalpel Kit STEREOTACTIC BIOPSY TRAY Basic Interventional Tray MRI Scalpel/Needle Kit Tray MRI BIOPSY TRAY MRI Breast Coil Headrest Drape MRI Breast Coil Drape Fischer Stereotactic Table Drape Lorad Table Drape Fischer AutoGuide Drape Interventional Drape Lorad Stage Drape MRI 20g x 9cm Inconel Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2008-05-29
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2006-04-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2006-04-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2006-04-05
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-05-29

Official Correspondent

Kelsey Bean

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QSUM BIOPSY DISPOSABLES LLC

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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

Registration Number	Establishment Name	Location
1052728	INVOTEC INTERNATIONAL, INC.	Jacksonville, FL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3004050971	VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.	Dong Guan City Guangdong, CN
3008489813	WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD	Weihai Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005675811. Last updated year: 2026. Please use registration number 3005675811 when referencing this establishment in official correspondence.