510(k) K913258
- Device
- DISPOSABLE INTROSSEOUS INFUSION NEEDLES
- Applicant
- COOK, INC.
- 510(k) number
- K913258
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-04
- Date received
- 1991-07-23
- 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
- Statement
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- APRIL LAVENDER
- Address
- 925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402
FDA Registration Numbers
- 3014654360
- 3005202235
- 1066444
- 3021286079
- 3008307705
- 3003589911
- 1450392
- 2183744
- 3013188547
- 3009742443
- 3001728571
- 1035907
- 3006260740
- 3016525500
- 3007007790
- 3012809732
- 3020294761
- 3003589279
- 3015142721
- 2031093
- 3030447506
- 3009504230
- 1423537
- 3019944216
- 3004143450
- 9611680
- 1064858
- 3000247873
- 3017210488
- 3014662855
- 3003915875
- 1045254
- 3009756327
- 3006948745
- 3019012929
- 3010377171
- 3033536319
- 3016884191
- 3030733800
- 8020040
- 3006942524
- 1125230
- 3003348846
- 3004417597
- 3015620563
- 3005669815
- 3004468406
- 9616791
- 3004055392
- 3009077131
- 3017509841
- 3036679495
- 1000118068
- 3014579161
- 8040619
- 3008998256
- 9681822
- 3010966701
- 3011453824
- 3003310007
- 8010418
- 9610825
- 1313700
- 8043385
- 3003895440
- 3014165712
- 3030446844
- 3012854006
- 3021186226
- 3011676762
- 2032112
- 3009888344
- 3004605321
- 3012104670
- 3006999064
- 1625685
- 3017717188
- 3009756153
- 3015485283
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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 |
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