510(k) K254273
- Device
- Verisafe Safety Sterile Needles (SSN)
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- 510(k) number
- K254273
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-16
- Date received
- 2025-12-30
- Regulation
- 880.5570
- Classification name
- Needle, Hypodermic, Single Lumen
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Zearou Yang
- Address
- # 1388 Cangxing St., Cangqian Community,Yuhang District Hangzhou City CN 311121 311121
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
510(k) summary PDF not indicated by FDA
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