FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROTEX SCREW BIOPSY NEEDLE
K Number: K854404
·
Decision Dec 2, 1985
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
24
Review Days
31
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Basic Information
- Device Name
- ROTEX SCREW BIOPSY NEEDLE
- K Number
- K854404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Meadox Surgimed, Inc.
- Date Received
- November 1, 1985
- Decision Date
- December 2, 1985
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM | Jun 9, 1993 | Substantially Equivalent |
| K911635 | MEADOX(R) SURGIMED(R) BIOPSY GUN II | Jun 20, 1991 | Substantially Equivalent |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | Mar 6, 1991 | Substantially Equivalent |
| K904582 | QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE | Feb 25, 1991 | Substantially Equivalent |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | Jan 30, 1991 | Substantially Equivalent |
| K902461 | MEADOX SURGIMED BIOPSY GUN AND NEEDLE | Jul 16, 1990 | Substantially Equivalent |
| K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE | Jun 20, 1989 | Substantially Equivalent |