Submission Details
| 510(k) Number | K855151 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 26, 1985 |
| Decision Date | February 19, 1986 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
FRITCH OPHTHALMIC ENDOSCOPE
Feb 1986
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K855151 is an FDA 510(k) clearance for the FRITCH OPHTHALMIC ENDOSCOPE, a Endoscope, Fiber Optic (Class II — Special Controls, product code GDB), submitted by Regtec (St. Petersburg, US). The FDA issued a Cleared decision on February 19, 1986, 55 days after receiving the submission on December 26, 1985. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | GDB — Endoscope, Fiber Optic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
Manufacturer
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