Cleared Traditional

K972521 - NAVIGATOR (STYLET) 2006

K972521 is an FDA 510(k) clearance for NAVIGATOR (STYLET) 2006, manufactured by Sil-Med Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K972521 · Sil-Med Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
86d
Days
Class 1
Risk

K972521 is an FDA 510(k) clearance for the NAVIGATOR (STYLET) 2006. Classified as Stylet, Surgical, General & Plastic Surgery (product code GAH), Class I - General Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 86 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.

FDA 510(k) Submission Details - K972521

510(k) Number K972521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date October 01, 1997
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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.

Regulatory Peers - GAH Stylet, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GAH) and FDA review panel - the closest regulatory comparables to K972521.
ARACHNOPHLEBECTOMY NEEDLE
K000932 · Advanced Medical Products, Inc. · May 2000
MARKMAN TEMPLATE SYSTEM
K970306 · Barry Markman, M.D. · Nov 1997
RAPID FIRE HAIR IMPLANTER CAROUSEL
K972918 · Apex Medical Products, LLC · Oct 1997
CALVITRON HAIR TRANSPLANT SYSTEM
K952737 · Medicamat S.A. · Oct 1995
HAIR TRANSPLANT PUNCH, MULTIPLH
K770970 · Padgett Instruments, Inc. · Oct 1977
K972521 · NAVIGATOR (STYLET) 2006
Download PDF FDA Summary Sil-Med Corp.