RADLITE TISSUE RETRACTOR SYSTEM— 510(k) K022989

Name: FDA 510(k) clearance K022989
Creator: U.S. Food and Drug Administration
Published: 2002-11-25

Substantially Equivalent

Genzyme Biosurgery

FDA 510(k) clearance K022989 for RADLITE TISSUE RETRACTOR SYSTEM, Substantially Equivalent on 2002-11-25. Applicant: Genzyme Biosurgery. Device class: 2.

Clearance details

Applicant: Genzyme Biosurgery
Product code: Code FSW
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2002-09-09
Decision date: 2002-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fall River, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSW

view all

K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)2002-02-01
K943342 — MEDICAM XENON LIGHT SOURCE1994-10-17
K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE1993-11-18
K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT1992-09-02
K913135 — LM-300TWIN1991-09-18

More clearances from Genzyme Biosurgery

view all

K031554 — S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM2003-07-25
K030212 — MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE2003-03-27
K022410 — SAPH-LOOP LIGATING LOOP2002-08-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.