510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860329Substantially Equivalent

Fyodorov Radial Keratotomy Marker Set

Med-Tech Develoment Corp., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860329 is the FDA 510(k) clearance record for FYODOROV RADIAL KERATOTOMY MARKER SET, a class II device, cleared for Med-Tech Develoment Corp. on under FDA product code HHR (Laser, Surgical, Gynecologic). FDA records list 5 510(k) clearances for Med-Tech Develoment Corp., from to . As of , FDA records show no recalls naming K860329.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HHR Laser, Surgical, Gynecologic
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Med-Tech Develoment Corp. 11300 49th St. N., Clearwater FL
Third party review
No

Clearances, product code HHR

Trailing 12 months

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

FDA records show no clearances under product code HHR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHR, 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