510(k) K123766
- Device
- NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
- Applicant
- NOVO NORDISK INC.
- 510(k) number
- K123766
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-15
- Date received
- 2012-12-07
- 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
- LOIS KOTKOSKIE, PH. D
- Address
- P.O Box 846 Plainsboro NJ US 08536 08536
FDA Registration Numbers#
- 3007407626
- 3027338968
- 3004911384
- 3012302888
- 8031563
- 2320762
- 3022699058
- 3013421458
- 3015859709
- 3004054016
- 3011088743
- 3012187635
- 1000563940
- 3006425876
- 3018125942
- 3012116434
- 9680602
- 3005841027
- 3003681915
- 8021764
- 3014662855
- 3011460807
- 3014456066
- 9612057
- 9610847
- 3008727519
- 9616088
- 3012102437
- 3009756153
- 9612030
- 9681835
- 3007384659
- 1019003
- 1017294
- 1313700
- 3030626857
- 3031233007
- 1649518
- 3005798905
- 3033589330
- 3006371704
- 3003310007
- 3007441619
- 3015142721
- 3013481097
- 2025816
- 3000247873
- 2032098
- 9680222
- 3010621964
- 2243072
- 3033536319
- 3007007790
- 3010384323
- 9610825
- 3006846316
- 3014747754
- 3021067373
- 3003120666
- 3007895168
- 3014615644
- 3034667025
- 2032227
- 3002579136
- 3013557562
- 3015724777
- 3016443334
- 3003755939
- 3016831076
- 3010667733
- 3012039263
- 1037885
- 2650089
- 3014159736
- 3008782867
- 1226544
- 3030446844
- 9680794
- 2032112
- 1067162
Source Documents#
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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