510(k) K231255
- Device
- NovoFine® Plus
- Applicant
- Novo Nordisk, Inc.
- 510(k) number
- K231255
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-25
- Date received
- 2023-05-01
- Regulation
- 880.5570
- Classification name
- Needle, Hypodermic, Single Lumen
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hiral Palkhiwala Shah
- Address
- P.O Box 846 Plainsboro NJ US 08536 08536
FDA Registration Numbers#
- 1222780
- 3004468406
- 1423537
- 3016685880
- 1221765
- 1063851
- 3012187743
- 3019012929
- 1000484830
- 8041145
- 3009761558
- 3034669683
- 3021169199
- 3014747754
- 9611446
- 2183771
- 3003974574
- 3015997711
- 3008381300
- 8040619
- 3004054016
- 2433012
- 3013633270
- 1054241
- 1928237
- 3006380458
- 3004192065
- 9612057
- 3020831613
- 3009756327
- 1410248
- 3007508552
- 3029755538
- 9681835
- 3008729892
- 2032810
- 1721183
- 9610847
- 9610825
- 9681821
- 1220477
- 3021286079
- 3015176914
- 3010055973
- 3007766601
- 3010160527
- 3014570560
- 3010864832
- 1450743
- 3022699058
- 2243072
- 3007344957
- 1036836
- 9616074
- 9614868
- 1820334
- 1213809
- 3010377171
- 3004961578
- 1417485
- 9612030
- 1061124
- 1526863
- 3012410077
- 3017509841
- 1017768
- 3029901632
- 3006371704
- 3030733800
- 3016904853
- 2320762
- 3005798905
- 3015140199
- 3012104670
- 3013481097
- 3008102042
- 9611680
- 3017494520
- 3015724078
Source Documents#
Other 510(k) Records For Product Code FMI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | 2026-03-25 |
| K253047 | PRESSONE™ | Nipro Medical Corporation | 2026-03-24 |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| K252886 | Pen Needle | Hh Global Technology, Inc. | 2026-01-06 |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025-11-21 |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025-10-16 |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 2025-07-30 |
| K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025-07-24 |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025-07-08 |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025-05-29 |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | 2025-04-18 |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025-04-04 |
| K250658 | SureFine Pen Needle | Shina Med Corporation | 2025-04-03 |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 |