Anti-Stick Syringe with Integral Hypodermic Needle/Vanishpoint Syringe
FDA 510(k) K973301 · Retractable Technologies, Inc.
510(k) numberK973301
Submission
- Device name
- Anti-Stick Syringe with Integral Hypodermic Needle/Vanishpoint Syringe
- Applicant
- Retractable Technologies, Inc.
Little Elm, TX, US - Received
- September 2, 1997
- Decision date
- November 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEG – Syringe, Antistick
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K230287 | SaviSafe Safety DeviceMEG · Traditional | Suzhou Savicred Biotechnology Co., Ltd. | 11/21/2023SE |
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| K220114 | PowerPAK SyringeMEG · Traditional | Vault Paragon Group, Inc. | 01/25/2023SE |
| K221981 | SafeR Syringe and SafeR StingMEG · Traditional | Roncadelle Operations Srl | 12/29/2022SE |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 11/23/2022SE |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/01/2022SE |
More from Jiangsu Kangbao Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K202325 | EasyPoint Blood Collection PlusJKA · Traditional | 04/09/2021SE |
| K133635 | Easypoint NeedleFMI · Traditional | 06/17/2014SE |
| K122355 | Vanishpoint Blood Collection SetJKA · Traditional | 08/23/2013SE |
| K112512 | Vanishpoint Blood Collection SetFPA · Traditional | 10/20/2011SE |
| K101708 | Patient Safe Luer CapFMF · Traditional | 02/24/2011SE |
| K081420 | Vanishpoint I.V. CatheterFOZ · Abbreviated | 11/07/2008SE |
| K072654 | Patient Safe SyringeFMF · Traditional | 12/14/2007SE |
| K051355 | Vanishpoint I.V. CatheterFOZ · Traditional | 09/23/2005SE |
| K980069 | Vanishpoint SyringeMEG · Traditional | 02/12/1998SE |
| K971763 | Blood Collection Tube Holder Vanishpoint Tube Holder/Small Tube AdapterFMI · Traditional | 08/26/1997SE |
Questions and answers
When was Anti-Stick Syringe with Integral Hypodermic Needle/Vanishpoint Syringe cleared by the FDA?
Anti-Stick Syringe with Integral Hypodermic Needle/Vanishpoint Syringe (K973301) received a 510(k) decision of Substantially Equivalent on November 7, 1997, 66 days after the submission was received.
What is the product code of K973301?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.