Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/ML
FDA 510(k) K062318 · Biotop Technology Co., Ltd.
510(k) numberK062318
Submission
- Device name
- Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/ML
- Applicant
- Biotop Technology Co., Ltd.
Taipei, TW - Received
- August 9, 2006
- Decision date
- January 3, 2007
- 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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| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional | Methyl Co., Ltd. | 02/18/2026SE |
| K250847 | VaporShieldMEG · Traditional | Vault Paragon Group, Inc. | 12/12/2025SE |
| K230287 | SaviSafe Safety DeviceMEG · Traditional | Suzhou Savicred Biotechnology Co., Ltd. | 11/21/2023SE |
| K231165 | Shina Syringe; Shina Safety SyringeMEG · Traditional | Shina Med Corporation | 10/27/2023SE |
| K231907 | Medline Safety Insulin and TB SyringesMEG · Traditional | Medline Industries, LP | 10/18/2023SE |
| 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 |
|---|---|---|
| K043038 | Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/MLMEG · Special | 12/22/2004SE |
| K041970 | Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and 10CC/MLMEG · Special | 08/03/2004SE |
| K032747 | Biotop Djt-A Safety SyringeMEG · Traditional | 05/11/2004SE |
Questions and answers
When was Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/ML cleared by the FDA?
Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/ML (K062318) received a 510(k) decision of Substantially Equivalent on January 3, 2007, 147 days after the submission was received.
What is the product code of K062318?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.