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510(k) K022989

RADLITE TISSUE RETRACTOR SYSTEM by Genzyme Biosurgery — Product Code FSW

K022989 is an FDA 510(k) premarket notification submitted by Genzyme Biosurgery for the device "RADLITE TISSUE RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 2002. The device falls under product code FSW (Light, Surgical, Endoscopic), a Class II device regulated under 21 CFR 878.4580. Genzyme Biosurgery has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2002
Date Received
September 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Endoscopic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Genzyme Biosurgery

  • K031554 — S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (July 25, 2003)
  • K030212 — MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE (March 27, 2003)
  • K022410 — SAPH-LOOP LIGATING LOOP (August 20, 2002)

Other clearances for product code FSW

  • K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (February 1, 2002)
  • K943342 — MEDICAM XENON LIGHT SOURCE (October 17, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K894319 — MEDICAL DYNAMICS LIGHT SOURCE (October 3, 1989)
  • K870898 — ULTRA-LUX LIGHT SOURCE (March 18, 1987)

FDA data resources