FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
K Number: K970803
·
Decision May 29, 1997
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
13
Review Days
86
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Basic Information
- Device Name
- ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
- K Number
- K970803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Retractable Technologies, Inc.
- Date Received
- March 4, 1997
- Decision Date
- May 29, 1997
- Product Code
- MEG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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Other Clearances by Retractable Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202325 | EasyPoint Blood Collection Plus | Apr 9, 2021 | Substantially Equivalent |
| K133635 | EASYPOINT NEEDLE | Jun 17, 2014 | Substantially Equivalent |
| K122355 | VANISHPOINT BLOOD COLLECTION SET | Aug 23, 2013 | Substantially Equivalent |
| K112512 | VANISHPOINT BLOOD COLLECTION SET | Oct 20, 2011 | Substantially Equivalent |
| K101708 | PATIENT SAFE LUER CAP | Feb 24, 2011 | Substantially Equivalent |
| K081420 | VANISHPOINT I.V. CATHETER | Nov 7, 2008 | Substantially Equivalent |
| K072654 | PATIENT SAFE SYRINGE | Dec 14, 2007 | Substantially Equivalent |
| K051355 | VANISHPOINT I.V. CATHETER | Sep 23, 2005 | Substantially Equivalent |
| K980069 | VANISHPOINT SYRINGE | Feb 12, 1998 | Substantially Equivalent |
| K973301 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE | Nov 7, 1997 | Substantially Equivalent |