510(k) K132681
- Device
- SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
- Applicant
- SOL-MILLENNIUM MEDICAL, INC.
- 510(k) number
- K132681
- Product code
- MEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-22
- Date received
- 2013-08-28
- 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
- JIM BARLEY
- Address
- 5415 Sugarloaf Pkwy., Suite 2203 Lawrenceville GA US 30043 30043
FDA Registration Numbers#
- 3012461127
- 3022699058
- 3004425647
- 3030626857
- 1647137
- 9680794
- 1911916
- 3020298301
- 1915484
- 8021538
- 3020294761
- 3014315664
- 3012307300
- 3003829571
- 8040619
- 9681413
- 3002807968
- 3005246939
- 3015142721
- 1219611
- 3004458481
- 3014819517
- 3010131137
- 9610847
- 3004143450
- 3005202235
- 3018681450
- 3001124136
- 3003681915
- 3012187743
- 2183744
- 3006142663
- 3017509841
- 3004416208
- 9613304
- 3007392007
- 3027338968
- 3008307705
- 3013513377
- 3007590959
- 3013187142
- 3017770710
- 9615588
- 3034667025
- 3038220293
- 3014570560
- 1213809
- 3002907620
- 3031259044
- 3043226252
- 1319639
- 3015620563
- 3005405146
- 3009746425
- 3008789114
- 3000126234
- 3012421607
- 3005670221
- 3007490412
- 3003902955
- 3029328631
- 1920898
- 1921846
- 1423507
- 1058584
- 3014162214
- 3013557562
- 3011689956
- 3004496829
- 3016904853
- 3030089798
- 3033536319
- 3023339256
- 3036722184
- 3007007790
- 3007279404
- 1649518
- 3014747754
- 1417592
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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