510(k) K133635
- Device
- EASYPOINT NEEDLE
- Applicant
- RETRACTABLE TECHNOLOGIES, INC.
- 510(k) number
- K133635
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-17
- Date received
- 2013-11-26
- 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
- RHONDA WELLS
- Address
- 511 Lobo Ln. Little Elm TX US 75068 75068
FDA Registration Numbers#
- 1450392
- 9616157
- 3014649053
- 9610825
- 3003681915
- 3011088743
- 3016525500
- 3013496867
- 3018507299
- 3030626857
- 1915484
- 1313700
- 1625685
- 3010419931
- 3015997711
- 3009746425
- 1217831
- 3010621964
- 3017494520
- 3009761558
- 3014456066
- 3012410077
- 3020294761
- 3014579161
- 3010155648
- 3005405146
- 2025816
- 3008009298
- 3010160527
- 2020394
- 3016884191
- 3006380458
- 3027332508
- 3018681450
- 3004416208
- 3023274465
- 3009328501
- 3004138517
- 3011287770
- 3010175289
- 3010377171
- 3029755538
- 3007817041
- 3004055392
- 3014393881
- 3013221738
- 9611680
- 2521402
- 3017509841
- 3035111606
- 3003542872
- 3011237770
- 8020785
- 3012354669
- 3043226252
- 3009742443
- 3005798905
- 3010384323
- 3026211706
- 3043709866
- 1018233
- 3021169199
- 3009498536
- 3003310007
- 3011689956
- 3038294399
- 3002907620
- 1721686
- 3004468406
- 3008449424
- 1055236
- 3010223109
- 3026478941
- 3009518015
- 3014819517
- 9617604
- 3010132111
- 3017636737
- 1220905
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 |
Legacy Summary#
summary
FDA Review#
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