Special Sprotte, Chiba, DR Steinhoff Kit
FDA 510(k) K063697 · PAJUNK GmbH Medizintechnologie
510(k) numberK063697
Submission
- Device name
- Special Sprotte, Chiba, DR Steinhoff Kit
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- December 13, 2006
- Decision date
- February 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/12/2026SE |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | Argon Medical Devices, Inc. | 02/23/2026SE |
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| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
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| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0HAW · Special | 02/22/2023SE |
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Questions and answers
When was Special Sprotte, Chiba, DR Steinhoff Kit cleared by the FDA?
Special Sprotte, Chiba, DR Steinhoff Kit (K063697) received a 510(k) decision of Substantially Equivalent on February 14, 2007, 63 days after the submission was received.
What is the product code of K063697?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.