510(k) K250262
- Device
- GO-PEN®
- Applicant
- Go-Pen Aps
- 510(k) number
- K250262
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-24
- Date received
- 2025-01-29
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Ole Nielsen
- Address
- Diplomvej 381 C/O Dtu Science Park Kongens Lyngby DK 2800 2800
FDA Registration Numbers
- 1450662
- 3006788678
- 3005202235
- 1416980
- 3029960285
- 1066444
- 2027062
- 3012833053
- 1043534
- 3008307705
- 3003589911
- 3004464325
- 2183744
- 1037885
- 3013188547
- 3009039068
- 3009742443
- 3005862821
- 1035907
- 3007007790
- 3012809732
- 3003589279
- 3015142721
- 2032521
- 2649614
- 3030447506
- 9680602
- 1219655
- 3014314985
- 1319660
- 1423537
- 3005186124
- 3003704957
- 1423929
- 3033589330
- 3006950086
- 3004143450
- 3027339877
- 1064858
- 3000247873
- 3014662855
- 3007084575
- 3012302888
- 3012341425
- 3006948745
- 3010377171
- 3033536319
- 2025870
- 9612152
- 3010331645
- 3003348846
- 3015620563
- 2530154
- 3005669815
- 3007594734
- 3013561817
- 9610993
- 3015173212
- 3009077131
- 3017509841
- 2183449
- 3036679495
- 3007663067
- 3011500374
- 3004024955
- 3014579161
- 8040619
- 3010966701
- 3021067373
- 3011453824
- 3003310007
- 8010418
- 9610825
- 1061927
- 1313700
- 1000359047
- 1000312731
- 3006571738
- 2249062
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code FMF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | 2025-02-05 |
| K242434 | Insulin Syringes | Chirana T. Injecta | 2024-12-24 |