510(k) K063755
- Device
- PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
- Applicant
- SMITHS MEDICAL ASD, INC.
- 510(k) number
- K063755
- Product code
- MEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-27
- Date received
- 2006-12-19
- Regulation
- 880.5860
- Classification name
- Syringe, Antistick
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN FARIAS
- Address
- 10 Bowman Dr. Keene NH US 03431 03431
FDA Registration Numbers#
- 3004416208
- 2183771
- 3003902955
- 3014312726
- 3010621964
- 1920898
- 3005798905
- 3020294761
- 3038356900
- 3012116434
- 3014819517
- 1035907
- 3023339256
- 3010864832
- 3008789114
- 3004496829
- 3009746425
- 3008719222
- 3005246939
- 3008307705
- 3030733800
- 3018681450
- 3022699058
- 3013187142
- 3007279404
- 3033536319
- 3012050423
- 3016904853
- 3001124136
- 3015142721
- 3000126234
- 3010515547
- 3036679495
- 2243072
- 3012039263
- 3010405396
- 3044026004
- 3006142663
- 3037918935
- 3012307300
- 3013298431
- 1649518
- 3034667025
- 3027338968
- 3012187743
- 1911916
- 3010026090
- 3014570560
- 1647137
- 3014456066
- 3010830834
- 3014315664
- 3007441619
- 3043226252
- 1220477
- 3002907620
- 3012809732
- 9616482
- 2183744
- 3029755538
- 8021538
- 2025816
- 3010131137
- 3035111606
- 9680794
- 3030626857
- 3012421607
- 3015474594
- 1921846
- 3015528193
- 9613304
- 3005202235
- 1213809
- 3012494290
- 3015972753
- 1417592
- 3024508819
- 3005405146
- 1423537
- 3042370483
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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