510(k) K941589
- Device
- SYRINGE FILTER DEVICES
- Applicant
- GELMAN SCIENCES, INC.
- 510(k) number
- K941589
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-06
- Date received
- 1994-03-31
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- 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
- MITCHELL L EHRLICH
- Address
- 600 S Wagner Rd. Ann Arbor MI US 48103 48103
FDA Registration Numbers#
- 3042953454
- 9680794
- 2183449
- 3009107690
- 3006891665
- 3013496867
- 3008307705
- 3011689956
- 3012410077
- 3012470322
- 3030446844
- 3015225571
- 3014262693
- 1410248
- 3022699058
- 3005841027
- 3006787036
- 1526534
- 3010400367
- 3036978618
- 3001124136
- 3004464325
- 2025648
- 3012809732
- 1423929
- 3008868758
- 3002807090
- 3005581234
- 9616679
- 2433012
- 3043226252
- 3016727307
- 3010120148
- 3015140199
- 3020460367
- 3019807891
- 1220477
- 3005186124
- 3010462274
- 1417485
- 1225112
- 3004111573
- 3010934635
- 3008789114
- 3009595577
- 3010321647
- 3012448339
- 2648666
- 1724474
- 2244771
- 3010032115
- 3010405396
- 8010418
- 9615588
- 1017768
- 3015620563
- 1450662
- 9610847
- 3045857302
- 3020138744
- 3015054258
- 1721183
- 3008522639
- 1000312731
- 2030624
- 3010026090
- 3034676720
- 3025432964
- 8031563
- 3013557562
- 3031233007
- 3030089798
- 3019269298
- 1211998
- 2027062
- 3014312726
- 3043022296
- 3027242374
- 3013561817
Source Documents#
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | 2026-08-26 |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | 2026-08-25 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026-08-14 |
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases