Lacimal Intubation Sets
FDA 510(k) K831901 · Visitec Co.
510(k) numberK831901
Submission
- Device name
- Lacimal Intubation Sets
- Applicant
- Visitec Co.
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 12, 1983
- 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 |
| K833671 | Sterile Oil and GuidewireHNL · Traditional | CooperVision, Inc. | 01/10/1984SE |
| 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 |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Lacimal Intubation Sets cleared by the FDA?
Lacimal Intubation Sets (K831901) received a 510(k) decision of Substantially Equivalent on July 12, 1983, 28 days after the submission was received.
What is the product code of K831901?
The FDA product code is HNL – Probe, Lachrymal, a Class I (low risk) device regulated under 21 CFR 886.4350.