510(k) K200431
- Device
- 3D GraftRasp System
- Applicant
- SurGenTec
- 510(k) number
- K200431
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-18
- Date received
- 2020-02-21
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andrew Shoup
- Address
- 911 Clint Moore Rd. Boca Raton FL US 33847 33847
FDA Registration Numbers#
- 3042370483
- 1219205
- 3008789114
- 3003974574
- 2650089
- 3009211636
- 3011270181
- 3014680149
- 8010674
- 3010432890
- 1019003
- 2011171
- 3007193505
- 8031007
- 3012329552
- 3013680140
- 3025603301
- 1647137
- 3043603327
- 3000247873
- 3039435934
- 3015806723
- 3041276591
- 3006788678
- 3014456066
- 3005246939
- 3003704957
- 3015539532
- 3031983053
- 1417592
- 3008650117
- 3004111573
- 3045857302
- 3014570560
- 3009746061
- 1217831
- 3009595577
- 3008808123
- 3010515547
- 1530671
- 3015231789
- 3007384659
- 3012494290
- 3007084575
- 3020138744
- 3034669683
- 1424263
- 3015151147
- 3004161147
- 3003829571
- 2530154
- 3010131137
- 3015422213
- 3036756245
- 3031233007
- 9681413
- 1643817
- 3008770691
- 3010032115
- 3016851379
- 3023228837
- 1047843
- 3004425647
- 3012050423
- 1319660
- 3006948745
- 3030089798
- 3013466775
- 3010026090
- 3004024955
- 3013404959
- 1644312
- 9617594
- 3007344957
- 2027754
- 1724474
- 3014747754
- 3002808227
- 3005813632
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