Cleared Traditional

K022989 - RADLITE TISSUE RETRACTOR SYSTEM

K022989 is an FDA 510(k) clearance for RADLITE TISSUE RETRACTOR SYSTEM, manufactured by Genzyme Biosurgery. The device is a Class 2 General & Plastic Surgery device with product code FSW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K022989 · Genzyme Biosurgery · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
77d
Days
Class 2
Risk

K022989 is an FDA 510(k) clearance for the RADLITE TISSUE RETRACTOR SYSTEM. Classified as Light, Surgical, Endoscopic (product code FSW), Class II - Special Controls.

Submitted by Genzyme Biosurgery (Fall River, US). The FDA issued a Cleared decision on November 25, 2002 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 - K022989

510(k) Number K022989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date November 25, 2002
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSW Device Classification - Class 2, Special Controls

Product Code FSW Light, Surgical, Endoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 - FSW Light, Surgical, Endoscopic

All 7
Devices cleared under the same product code (FSW) and FDA review panel - the closest regulatory comparables to K022989.
XENALIGHT MODELS # AX9125 (100-120V~)
K013511 · Aculux, Inc. · Feb 2002
MEDICAM XENON LIGHT SOURCE
K943342 · M.P. Video, Inc. · Oct 1994
CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
K934337 · Cuda Products Co. · Nov 1993
ILLUMINATOR IV MINOR SURGERY LIGHT
K922279 · Medical Illumination, Inc. · Sep 1992
LM-300TWIN
K913135 · Leisegang Medical, Inc. · Sep 1991
MEDICAL DYNAMICS LIGHT SOURCE
K894319 · Medical Dynamics, Inc. · Oct 1989
K022989 · RADLITE TISSUE RETRACTOR SYSTEM
Download PDF FDA Summary Genzyme Biosurgery