Ethicon Lacrimal Stent
FDA 510(k) K812255 · ETHICON, Inc.
510(k) numberK812255
Submission
- Device name
- Ethicon Lacrimal Stent
- Applicant
- ETHICON, Inc.
Mchenry, IL, US - Received
- August 12, 1981
- Decision date
- August 20, 1981
- 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 |
| 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 |
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Questions and answers
When was Ethicon Lacrimal Stent cleared by the FDA?
Ethicon Lacrimal Stent (K812255) received a 510(k) decision of Substantially Equivalent on August 20, 1981, 8 days after the submission was received.
What is the product code of K812255?
The FDA product code is HNL – Probe, Lachrymal, a Class I (low risk) device regulated under 21 CFR 886.4350.