510(k) K152339
- Device
- Unifine Pentips/ Unifine Pentips Plus
- Applicant
- OWEN MUMFORD LTD
- 510(k) number
- K152339
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-24
- Date received
- 2015-08-19
- 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
- Patty Cronan
- Address
- Brook Hill Woodstock GB OX20 ITU OX20 ITU
FDA Registration Numbers#
- 3010384323
- 3010934635
- 1055927
- 3005798905
- 3017494520
- 3000247873
- 3034667025
- 3012944064
- 3014654360
- 3012410077
- 3030446758
- 3013764800
- 9614033
- 3015620563
- 3017210488
- 1066741
- 3013188547
- 3012680643
- 3002682307
- 3018125942
- 1222780
- 3015142721
- 3005202235
- 2032810
- 2031093
- 3004127962
- 3001728571
- 9680222
- 3010621964
- 3010830834
- 1018233
- 3035642068
- 3005674478
- 8041187
- 9610847
- 3023316
- 3036679495
- 1647137
- 3012438919
- 1417485
- 3014312726
- 2027487
- 3003589911
- 3029755538
- 3000126234
- 3012116434
- 2427500
- 3019944216
- 3003895440
- 3004111573
- 3009761558
- 3008307705
- 3004425647
- 2523676
- 3014456066
- 9616074
- 3015997711
- 3004468406
- 3009746425
- 2024024
- 3020138744
- 3010223109
- 9615588
- 3010055973
- 1034525
- 3010160527
- 3009853488
- 3022699058
- 3011237770
- 3002907620
- 3004099493
- 1043214
- 3027332508
- 3020298301
- 3005405146
- 1450743
- 3006371704
- 3014165712
- 3002808227
Source Documents#
Other 510(k) Records For Product Code FMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | 2025-04-18 |
Legacy Summary#
summary
FDA Review#
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