510(k) K942221
- Device
- IRRIGATION TRAY WITH PISTON SYRINGE
- Applicant
- TRINITY LABORATORIES, INC.
- 510(k) number
- K942221
- Product code
- FMF
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1994-08-05
- Date received
- 1994-05-06
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PARTH BASUMALLIK
- Address
- 201 Kiley Dr. Salisbury MD US 21801 21801
FDA Registration Numbers#
- 1423537
- 3013576619
- 3016685880
- 3023851856
- 1063851
- 3012187743
- 3005064037
- 1000484830
- 8041145
- 3009761558
- 3034669683
- 1819470
- 3008812241
- 8031563
- 3013404959
- 3014747754
- 8040700
- 3009551627
- 3013700547
- 2517117
- 3005862821
- 2320767
- 2183771
- 3003974574
- 3015997711
- 3010400367
- 1018120
- 8040619
- 1047843
- 2032521
- 3004054016
- 2433012
- 1054241
- 3008868758
- 2245304
- 1928237
- 3006380458
- 2650089
- 3004192065
- 9612057
- 1410248
- 3029755538
- 1219930
- 9681835
- 3010120148
- 1721183
- 9610847
- 3004024955
- 9610825
- 9681821
- 1220477
- 1019003
- 3031788372
- 3014570560
- 3009417901
- 3010864832
- 1450743
- 3022699058
- 2243072
- 3007344957
- 3010221586
- 1036836
- 3009337401
- 3011230048
- 1213809
- 3010377171
- 1417485
- 9612030
- 1061124
- 3012187635
- 3036722184
- 3016733629
- 3015724777
- 3007193283
- 1226146
- 3015967359
- 3012410077
- 3017509841
- 1017768
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | 2025-08-22 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025-06-24 |
| K250262 | GO-PEN® | Go-Pen Aps | 2025-04-24 |
Legacy Summary#
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FDA Review#
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