Cleared Traditional

K981527 - MENTOR PATHWAY INTRODUCER/DILATOR

K981527 is an FDA 510(k) clearance for MENTOR PATHWAY INTRODUCER/DILATOR, manufactured by Mentor Corp.. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 72-day FDA review.

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

FDA 510(k) Submission Details - K981527

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPB Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K981527.
RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
K990602 · Tecsa Technical Services · Jul 1999
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
K981922 · Microaire Surgical Instruments, Inc. · Dec 1998
LYSONIX SUCTION LIPOPLASTY SYSTEM
K980771 · Lysonix, Inc. · Jul 1998
PSI-TEC LIPOSUCTION ASPIRATOR
K981215 · Byron Medical · Jul 1998
LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
K981172 · Byron Medical · Jun 1998
LYSONIX LIPOPLASTY ACCESS PORT
K980763 · Lysonix, Inc. · May 1998