Daum Double-Shoot Bisopsy Gun
FDA 510(k) K010037 · Daum GmbH
510(k) numberK010037
Submission
- Device name
- Daum Double-Shoot Bisopsy Gun
- Applicant
- Daum GmbH
Crofton, MD, US - Received
- January 4, 2001
- Decision date
- March 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
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| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
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More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K991366 | Daum Mri/Conventional Biopsy KitKNW · Traditional | 06/25/1999SE |
| K990782 | Daum Neurogate TrocarKNW · Traditional | 04/28/1999SE |
| K990278 | Daum Neurocut NeurobiopsyneedleKNW · Traditional | 03/30/1999SE |
| K981320 | Daum Bone Biopsy SetKNW · Traditional | 06/29/1998SE |
| K974631 | Daum Neurobiopsy NeedleKNW · Traditional | 03/09/1998SE |
| K974576 | Daum BiopsygunKNW · Traditional | 03/06/1998SE |
| K974575 | Daum Aspirationbiopsy NeedleKNW · Traditional | 03/06/1998SE |
| K974574 | Daum Neuropuncture NeedleKNW · Traditional | 03/06/1998SE |
| K970037 | TargogridLNH · Traditional | 03/12/1997SE |
Questions and answers
When was Daum Double-Shoot Bisopsy Gun cleared by the FDA?
Daum Double-Shoot Bisopsy Gun (K010037) received a 510(k) decision of Substantially Equivalent on March 22, 2001, 77 days after the submission was received.
What is the product code of K010037?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.