510(k) K043038
- Device
- BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
- Applicant
- BIOTOP TECHNOLOGY CO., LTD.
- 510(k) number
- K043038
- Product code
- MEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-12-22
- Date received
- 2004-11-04
- Regulation
- 880.5860
- Classification name
- Syringe, Antistick
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK LIEN
- Address
- 12 F-2, # 130 Chung-Hsiao E.Rd.,Sec.2 Taipei TW 100 100
FDA Registration Numbers#
- 3030733800
- 3004496829
- 3027338968
- 3007392007
- 3030626857
- 3005246939
- 3010864832
- 3012050423
- 3003681915
- 3014579161
- 3004099493
- 3035111606
- 3005798905
- 3005202235
- 3034667025
- 3016904853
- 3031259044
- 3003589279
- 3011287770
- 1911916
- 3013557562
- 3043226252
- 1035907
- 3009742443
- 1423507
- 3007279404
- 3015620563
- 3036722184
- 3015474594
- 9680794
- 3015142721
- 3010405396
- 3010131137
- 3004416208
- 3012116434
- 9613304
- 3044026004
- 1921846
- 3010085632
- 3038294399
- 3014312726
- 3009746425
- 3001124136
- 3029755538
- 3014747754
- 3005670221
- 3016685880
- 1920898
- 3038220293
- 3005405146
- 8021538
- 3023339256
- 2183744
- 3022699058
- 3024088964
- 3012809732
- 3013513377
- 3017509841
- 3014662855
- 1219611
- 1450743
- 3013187142
- 3036679495
- 3004425647
- 3017717188
- 8040619
- 2183771
- 3010147274
- 3002807968
- 3012646696
- 3004458481
- 3020298301
- 3015176887
- 3017770710
- 1213809
- 3004417597
- 3023228837
- 3010515547
- 3012187743
Source Documents#
Other 510(k) Records For Product Code MEG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | 2026-02-18 |
| K250847 | VaporShield | Vault Paragon Group, Inc. | 2025-12-12 |
| K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | 2023-11-21 |
| K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023-10-27 |
| K231907 | Medline Safety Insulin and TB Syringes | Medline Industries, LP | 2023-10-18 |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | Cardinal Health200, LLC | 2023-06-21 |
| K220114 | PowerPAK Syringe | Vault Paragon Group, Inc. | 2023-01-25 |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | 2022-12-29 |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co.,Ltd | 2022-11-23 |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022-11-01 |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-10-07 |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022-08-23 |
| K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2022-08-18 |
| K213077 | Automatically Retractable Safety Syringe | Zhejiang Lingyang Medical Apparatus Co., Ltd. | 2022-04-27 |
Legacy Summary#
summary
FDA Review#
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