510(k) K170247
- Device
- Lacriflow CL
- Applicant
- KANEKA PHARMA AMERICA LLC
- 510(k) number
- K170247
- Product code
- OKS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-18
- Date received
- 2017-01-27
- Regulation
- 510(k) Premarket Notification
- Classification name
- Lacrimal Stents And Intubation Sets
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ophthalmic
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Masaaki Fukunishi
- Address
- 546 Fifth Ave., 21st Floor New York NY US 10036 10036
FDA Registration Numbers#
- 1018470
- 3004467263
- 2029275
- 9614654
- 1450662
- 3006234743
- 3002807310
- 1929756
- 2031962
- 1424263
- 1649914
- 3015177648
- 1649518
- 3009761573
- 3010162973
- 2083373
- 1000286794
- 3002991496
- 1928237
- 9615745
- 2242450
Source Documents#
Other 510(k) Records For Product Code OKS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201892 | Ritleng®+ and Ritleng®+ PVP | Fci (France Chirurgie Instrumentation) Sas | 2021-03-11 |
| K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | 2020-12-18 |
| K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016-11-03 |
| K160710 | Oasis Lacrimal Intubation Set | Anodyne | 2016-05-13 |
| K142914 | DacryoCATH | Armadillo Biomedical, LLC | 2015-01-12 |
| K140290 | STOPLOSS JONES TUBE | Ljt Surgical, Ltd. | 2014-12-02 |
| K130375 | SELF-RETAINING BICANALICULUS INTUBATON SET II | Fci Sas (France Chirurgie Instrumentation) | 2013-12-04 |
| K123831 | OPHTACATH KIT | France Chirurgae Instrumentation | 2013-07-29 |
| K120886 | LACRIFAST | Hiroyasu Higuchi | 2012-12-17 |
| K113316 | DCS LACRIMAL STENT | Dcs Surgical, Inc. | 2012-11-08 |
| K113867 | LACRICATH LACRIMAL DUCT CATHETER | Quest Medical, Inc. | 2012-10-19 |
| K113508 | DACRYOCATH | Armadillo Biomedical, LLC | 2012-08-31 |
| K121142 | CRAWFORD BIOCANALICULUS INTUBATION | Fci Sas (France Chirurgie Instrumentation) | 2012-08-09 |
| K113536 | MASTERKA 40 MASTERKA 35 MASTERKA 30 | Fci Sas (France Chirurgie Instrumentation) | 2012-08-03 |
| K113118 | STENTUBE LACRIMAL INTUBATION SET | Quest Medical, Inc. | 2012-07-31 |
Legacy Summary#
summary
FDA Review#
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