OPHTACATH KIT
FDA 510(k) clearance K123831 · decided 2013-07-29
Clearance details
- K-number
- K123831
- Device name
- OPHTACATH KIT
- Applicant
- France Chirurgae Instrumentation
- Decision
- Substantially Equivalent
- Date received
- 2012-12-12
- Decision date
- 2013-07-29
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- OKS
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ritleng®+ and Ritleng®+ PVP (K201892) | Fci (France Chirurgie Instrumentation) Sas | 2021-03-11 |
| LacriJet® (K201606) | Fci (France Chirurgie Instrumentation) Sas | 2020-12-18 |
| Lacriflow CL (K170247) | Kaneka Pharma America, LLC | 2017-04-18 |
| Nunchaku (K161373) | Fci (France Chirurgie Instrumentation) | 2016-11-03 |
| Oasis Lacrimal Intubation Set (K160710) | Anodyne | 2016-05-13 |
| DacryoCATH (K142914) | Armadillo Biomedical, LLC | 2015-01-12 |
| STOPLOSS JONES TUBE (K140290) | Ljt Surgical, Ltd. | 2014-12-02 |
| SELF-RETAINING BICANALICULUS INTUBATON SET II (K130375) | Fci Sas (France Chirurgie Instrumentation) | 2013-12-04 |
| LACRIFAST (K120886) | Hiroyasu Higuchi | 2012-12-17 |
| DCS LACRIMAL STENT (K113316) | Dcs Surgical, Inc. | 2012-11-08 |
| LACRICATH LACRIMAL DUCT CATHETER (K113867) | Quest Medical, Inc. | 2012-10-19 |
| DACRYOCATH (K113508) | Armadillo Biomedical, LLC | 2012-08-31 |
Recalls involving this device
No recalls on record reference this clearance.