Submission Details
| 510(k) Number | K874253 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 1987 |
| Decision Date | July 12, 1988 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
K874253 - ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
(FDA 510(k) Clearance)
Jul 1988
Decision
266d
Days
Class 2
Risk
K874253 is an FDA 510(k) clearance for the ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA., a Laser For Gastro-urology Use (Class II — Special Controls, product code LNK), submitted by Minnesota Laser Corp. (Minneapolis, US). The FDA issued a Cleared decision on July 12, 1988, 266 days after receiving the submission on October 20, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.4810.
Device Classification
| Product Code | LNK — Laser For Gastro-urology Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
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