FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RANFAC CUT BIOPSY NEEDLE
K Number: K864139
·
Decision Nov 5, 1986
Classifications
1
FEI Numbers
321
Registration Numbers
322
Same Product Code
106
Applicant Total
12
Review Days
14
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Basic Information
- Device Name
- RANFAC CUT BIOPSY NEEDLE
- K Number
- K864139
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ranfac, Corp.
- Date Received
- October 22, 1986
- Decision Date
- November 5, 1986
- Product Code
- GAA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | May 22, 2015 | Substantially Equivalent |
| K140991 | RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE | Sep 11, 2014 | Substantially Equivalent |
| K131157 | RANFAC BONE MARROW ASPIRATION NEEDLE | Oct 22, 2013 | 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 |