Cleared Traditional

K972918 - RAPID FIRE HAIR IMPLANTER CAROUSEL

K972918 is an FDA 510(k) clearance for RAPID FIRE HAIR IMPLANTER CAROUSEL, manufactured by Apex Medical Products, LLC. The device is a Class 1 General & Plastic Surgery device with product code GAH cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K972918 · Apex Medical Products, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
81d
Days
Class 1
Risk

K972918 is an FDA 510(k) clearance for the RAPID FIRE HAIR IMPLANTER CAROUSEL. Classified as Stylet, Surgical, General & Plastic Surgery (product code GAH), Class I - General Controls.

Submitted by Apex Medical Products, LLC (Potomac, US). The FDA issued a Cleared decision on October 27, 1997 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Apex Medical Products, LLC devices

FDA 510(k) Submission Details - K972918

510(k) Number K972918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1997
Decision Date October 27, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

GAH Device Classification - Class 1, General Controls

Product Code GAH Stylet, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.