FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFETY BIOPSY NEEDLE SYSTEM
K Number: K140137
·
Decision Mar 25, 2014
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
20
Review Days
62
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Basic Information
- Device Name
- SAFETY BIOPSY NEEDLE SYSTEM
- K Number
- K140137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pfm Medical, Inc.
- Date Received
- January 22, 2014
- Decision Date
- March 25, 2014
- Product Code
- FCG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
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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| K213666 | NuCath Wedge Pressure Catheter | Oct 6, 2022 | Substantially Equivalent |
| K201137 | Asept Surgical Face Mask | Aug 19, 2020 | Substantially Equivalent |
| K192802 | primeMidline Catheters | Oct 28, 2019 | Substantially Equivalent |
| K173114 | primeMidline Catheters | Mar 7, 2018 | Substantially Equivalent |
| K122402 | LPP (LOW PROFILE PORT) | Jul 16, 2013 | Substantially Equivalent |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Mar 13, 2012 | Unknown |
| K110914 | TRIPLE LUMEN PFM PICC | Sep 21, 2011 | Substantially Equivalent |