FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY NEEDLE
K Number: K953880
·
Decision Sep 8, 1995
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
15
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIOPSY NEEDLE
- K Number
- K953880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biopsys Medical, Inc.
- Date Received
- August 18, 1995
- Decision Date
- September 8, 1995
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNW), ordered by most recent decision date.
Promisemed VeriEcto Automatic Biopsy Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EnCor EnCompass Breast Biopsy and Tissue Removal System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Resitu Slider 09 (RESL09)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Forcyte Autograft Harvest Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Biopsys Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970817 | MICROMARK CLIP | Sep 11, 1997 | Substantially Equivalent |
| K970565 | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) | Mar 28, 1997 | Substantially Equivalent |
| K963015 | SURGICAL STAPLE MARKER DEVICE (MODIFY) | Oct 7, 1996 | Substantially Equivalent |
| K960019 | RETRACTOR ARM CLAMP | Feb 9, 1996 | Substantially Equivalent |
| K953962 | FORCEPS | Sep 8, 1995 | Substantially Equivalent |
| K951326 | BIOPSY DEVICE ACCESSORY | May 15, 1995 | Substantially Equivalent |
| K951229 | MODIFIED BIOPSY NEEDLE | Apr 6, 1995 | Substantially Equivalent |
| K950006 | SURGICAL STAPLE MARKER | Mar 15, 1995 | Substantially Equivalent |
| K943863 | NEEDLE GUIDE | Dec 29, 1994 | Substantially Equivalent |
| K945573 | BIOPSY DEVICE ACCESSORY | Dec 9, 1994 | Substantially Equivalent |