510(k) K093109
- Device
- NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
- Applicant
- NOVO NORDISK INC.
- 510(k) number
- K093109
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-06-18
- Date received
- 2009-10-01
- Regulation
- 880.5570
- Classification name
- Needle, Hypodermic, Single Lumen
- 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
- CINDY CAO
- Address
- 100 College Rd. W. Princeton NJ US 08540 08540
FDA Registration Numbers#
- 9611680
- 3027338968
- 2320762
- 3022699058
- 3015859709
- 3004054016
- 3011088743
- 2020394
- 1000563940
- 3006425876
- 3010392991
- 3018125942
- 3012116434
- 3003915875
- 3005841027
- 3003681915
- 1223004
- 8021764
- 3014662855
- 3014456066
- 9612057
- 9610847
- 3011617315
- 9681822
- 3009756153
- 9612030
- 9681835
- 3007384659
- 3003895440
- 1313700
- 3030626857
- 3014649053
- 3031233007
- 3004416208
- 1649518
- 3005798905
- 3006371704
- 3003310007
- 3007441619
- 3015142721
- 3013481097
- 1213680
- 2032098
- 3000247873
- 9680222
- 2025816
- 3010621964
- 3027332508
- 1055927
- 2243072
- 2427500
- 3033536319
- 3007007790
- 3010384323
- 3006850123
- 3016884191
- 9614868
- 9610825
- 1030451
- 3008780388
- 3014747754
- 3009578786
- 3003120666
- 3007895168
- 3034667025
- 3013557562
- 3008102042
- 3018507299
- 3012039263
- 3019944216
- 3020294761
- 3030446844
- 3030714660
- 3012502601
- 9680794
- 2032112
- 9616791
- 3010085632
- 1836161
Source Documents#
Other 510(k) Records For Product Code FMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 |
| K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | 2026-07-29 |
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026-07-15 |
| K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026-06-10 |
| 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 |
Legacy Summary#
summary
FDA Review#
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