510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972918Substantially Equivalent

Rapid Fire Hair Implanter Carousel

Apex Medical Products, LLC, Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972918 is the FDA 510(k) clearance record for RAPID FIRE HAIR IMPLANTER CAROUSEL, a class I device, cleared for Apex Medical Products, LLC on under FDA product code GAH (Stylet, Surgical, General & Plastic Surgery). FDA records list one 510(k) clearance for Apex Medical Products, LLC. As of , FDA records show no recalls naming K972918.

Clearance record

Decision date
Received
(81 days to decision)
Product code
GAH Stylet, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Apex Medical Products, LLC 9109 Copenhaver Dr., Potomac MD
510(k) summary
Summary
Third party review
No

Clearances, product code GAH

Trailing 12 months

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

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