FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K Number: K032943
·
Decision Dec 17, 2003
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
124
Review Days
86
Basic Information
- Device Name
- STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
- K Number
- K032943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corp.
- Date Received
- September 22, 2003
- Decision Date
- December 17, 2003
- 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 Stryker Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K230045 | HipCheck | Sep 29, 2023 | Substantially Equivalent |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Jul 12, 2019 | Substantially Equivalent |
| K182359 | HipCheck | Dec 13, 2018 | Substantially Equivalent |
| K143399 | Stryker Footed Attachments and Cutting Accessories | May 8, 2015 | Substantially Equivalent |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Apr 23, 2015 | Substantially Equivalent |
| K150449 | LITe Plate System | Mar 20, 2015 | Substantially Equivalent |
| K142381 | Xia 3 Spinal System | Oct 21, 2014 | Substantially Equivalent |
| K133671 | ICONIX ALL SUTURE ANCHORS | Feb 28, 2014 | Substantially Equivalent |
| K122113 | MEMORY METAL STAPLES, EASYCLIP | Mar 12, 2013 | Substantially Equivalent |
| K122284 | HOFFMANN 3 | Oct 24, 2012 | Substantially Equivalent |