Data / Medical devices / United States / Qsum Biopsy Disposables LLC
Qsum Biopsy Disposables LLC: FDA-registered device maker in Pequot Lakes, MN, United States, 1 510(k) clearance
Qsum Biopsy Disposables LLC is registered with the FDA (registration 3005675811) in Pequot Lakes, MN, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 25, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005675811
- Address
- 8624 County Road 1 Sw, Pequot Lakes, MN, United States, 56472
- Owner or operator
- QSUM BIOPSY DISPOSABLES LLC (9085466)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 5, 2006
- Registered through
- 2026
- Brand names listed
- #11 MRI Disposable Scalpel Kit, Basic Interventional Tray, Fischer AutoGuide Drape, Fischer Stereotactic Table Drape, Interventional Drape, Lorad Stage Drape, Lorad Table Drape, MRI 20g x 9cm Inconel Needle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Specification developer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 1997 | K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Scalpel, One-Piece
- All makers of Drape, Surgical, Antimicrobial
- All makers of Gown, Surgical
Updated February 25, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.