Naso-Lacrimal Duct Insert
FDA 510(k) K770194 · Concept, Inc.
510(k) numberK770194
Submission
- Device name
- Naso-Lacrimal Duct Insert
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- January 31, 1977
- Decision date
- February 14, 1977
- 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 |
| 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 |
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| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Naso-Lacrimal Duct Insert cleared by the FDA?
Naso-Lacrimal Duct Insert (K770194) received a 510(k) decision of Substantially Equivalent on February 14, 1977, 14 days after the submission was received.
What is the product code of K770194?
The FDA product code is HNL – Probe, Lachrymal, a Class I (low risk) device regulated under 21 CFR 886.4350.