K812255 is an FDA 510(k) clearance for the ETHICON LACRIMAL STENT. This device is classified as a Probe, Lachrymal (Class I - General Controls, product code HNL).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1981, 8 days after receiving the submission on August 12, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K812255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1981 |
| Decision Date | August 20, 1981 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNL — Probe, Lachrymal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |