FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT
K Number: K845038
·
Decision Mar 11, 1985
Classifications
1
FEI Numbers
236
Registration Numbers
236
Same Product Code
27
Applicant Total
12
Review Days
74
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Basic Information
- Device Name
- BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT
- K Number
- K845038
- 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
- December 27, 1984
- Decision Date
- March 11, 1985
- Product Code
- GDF
- 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 |
|---|---|---|---|
| GDF | Guide, Needle, Surgical | FDA class 1 | General, Plastic Surgery |
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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 |
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| 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 |