Cleared Traditional

K990602 - RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES

K990602 is an FDA 510(k) clearance for RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES, manufactured by Tecsa Technical Services. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K990602 · Tecsa Technical Services · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
127d
Days
Class 2
Risk

K990602 is an FDA 510(k) clearance for the RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Tecsa Technical Services (Santa Barbara, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Tecsa Technical Services devices

FDA 510(k) Submission Details - K990602

510(k) Number K990602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1999
Decision Date July 01, 1999
Days to Decision 127 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
12d slower than avg
Panel avg: 115d · This submission: 127d
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 44
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K990602.
ACCELERATOR RECIPROCATING CANNULA
K001803 · Byron Medical · Aug 2000
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
K992855 · Xomed, Inc. · Jan 2000
MICRO-FRANCE LIPOSUCTION CANNULAS
K992282 · Xomed, Inc. · Sep 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
MENTOR PATHWAY INTRODUCER/DILATOR
K981527 · Mentor Corp. · Jul 1998