Sterile Oil and Guidewire
FDA 510(k) K833671 · CooperVision, Inc.
510(k) numberK833671
Submission
- Device name
- Sterile Oil and Guidewire
- Applicant
- CooperVision, Inc.
Southampton, GB - Received
- October 18, 1983
- Decision date
- January 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNL – Probe, Lachrymal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843491 | Concept Fiber Optic Canaliculus IntubaHNL · Traditional | Concept, Inc. | 10/05/1984SE |
| K840861 | Tse-Anderson Modified Lacrimal GroovHNL · Traditional | Hansen Ophthalmic Development Lab | 05/09/1984SE |
| K831901 | Lacimal Intubation SetsHNL · Traditional | Visitec Co. | 07/12/1983SE |
| K813187 | Pilling Lacrimal Intubation SystemHNL · Traditional | Narco Scientific | 01/28/1982SE |
| K812255 | Ethicon Lacrimal StentHNL · Traditional | ETHICON, Inc. | 08/20/1981SE |
| K802845 | Concept Canaliculus Intubation SetHNL · Traditional | Concept, Inc. | 12/17/1980SE |
| K801232 | Jackson Lacrimal Intubation SetHNL · Traditional | Storz Instrument Co. | 06/17/1980SE |
| K800089 | Crawford Lacrimal Intubation SetHNL · Traditional | Jedmed Instrument Co. | 03/03/1980SE |
| K770194 | Naso-Lacrimal Duct InsertHNL · Traditional | Concept, Inc. | 02/14/1977SE |
More from Concept, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…LPL · Special | 01/25/2024SE |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special | 02/04/2022SE |
| K213164 | Avaira VitalityLPL · Special | 10/26/2021SE |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…LPL · Special | 10/20/2020SE |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
Questions and answers
When was Sterile Oil and Guidewire cleared by the FDA?
Sterile Oil and Guidewire (K833671) received a 510(k) decision of Substantially Equivalent on January 10, 1984, 84 days after the submission was received.
What is the product code of K833671?
The FDA product code is HNL – Probe, Lachrymal, a Class I (low risk) device regulated under 21 CFR 886.4350.