510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855151Substantially Equivalent

Fritch Ophthalmic Endoscope

Regtec, St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855151 is the FDA 510(k) clearance record for FRITCH OPHTHALMIC ENDOSCOPE, a class II device, cleared for Regtec on under FDA product code GDB (Endoscope, Fiber Optic). FDA records list one 510(k) clearance for Regtec. As of , FDA records show no recalls naming K855151.

Clearance record

Decision date
Received
(55 days to decision)
Product code
GDB Endoscope, Fiber Optic
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Regtec P.O. Box 76298, St. Petersburg FL
Third party review
No

Clearances, product code GDB

Trailing 12 months

FDA records hold no clearances under product code GDB in the trailing twelve months.

FDA records show no clearances under product code GDB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260