Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and 130024
FDA 510(k) K070203 · Inviro Medical Devices, Inc.
510(k) numberK070203
Submission
- Device name
- Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and 130024
- Applicant
- Inviro Medical Devices, Inc.
Duluth, GA, US - Received
- January 22, 2007
- Decision date
- April 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | Cardinal Health200, LLC | 06/21/2023SE |
| 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 |
|---|---|---|
| K101359 | Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)FMF · Special | 08/20/2010SE |
| K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…MEG · Special | 09/04/2009SE |
| K092413 | Invirosnap 50 and 100 Unit Insulin Safety SyringesMEG · Special | 09/04/2009SE |
| K083851 | Inviroblunt Cannula with and Without Ez Wings, Models 120522 and 120022LHI · Special | 05/15/2009SE |
| K081436 | Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesFMF · Traditional | 10/22/2008SE |
| K071307 | Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003FMI · Traditional | 02/12/2008SE |
Questions and answers
When was Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and 130024 cleared by the FDA?
Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and 130024 (K070203) received a 510(k) decision of Substantially Equivalent on April 23, 2007, 91 days after the submission was received.
What is the product code of K070203?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.