FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RANFAC BONE MARROW ASPIRATION NEEDLE
K Number: K131157
·
Decision Oct 22, 2013
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
12
Review Days
181
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Basic Information
- Device Name
- RANFAC BONE MARROW ASPIRATION NEEDLE
- K Number
- K131157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ranfac, Corp.
- Date Received
- April 24, 2013
- Decision Date
- October 22, 2013
- 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 |
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Other Clearances by Ranfac, Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K162932 | Ranfac Fat Aspiration Cannula | Jan 19, 2017 | Substantially Equivalent |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel | Oct 19, 2015 | Substantially Equivalent |
| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | May 22, 2015 | Substantially Equivalent |
| K140991 | RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE | Sep 11, 2014 | Substantially Equivalent |
| K031344 | RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE | May 23, 2003 | Substantially Equivalent |
| K012224 | SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW | Aug 22, 2001 | Substantially Equivalent |
| K961922 | RDP-2 | Aug 9, 1996 | Substantially Equivalent |
| K951090 | INTRODUCER | Jul 11, 1995 | Substantially Equivalent |
| K930474 | NEEDLE, PNEUMOPERITONEUM, SPRING LOADED | Jul 23, 1993 | Substantially Equivalent |
| K864139 | RANFAC CUT BIOPSY NEEDLE | Nov 5, 1986 | Substantially Equivalent |