Cleared Traditional

K981527 - MENTOR PATHWAY INTRODUCER/DILATOR (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981527 · Mentor Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
72d
Days
Class 2
Risk

K981527 is an FDA 510(k) clearance for the MENTOR PATHWAY INTRODUCER/DILATOR. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on July 9, 1998 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5040 - 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 Mentor Corp. devices

Submission Details

510(k) Number K981527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1998
Decision Date July 09, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 114d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPB System, Suction, Lipoplasty For Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QPB System, Suction, Lipoplasty For Removal

All 55
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