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510(k) K880540

LIGHT, SURGICAL, FLOOR STANDING by Ferguson Medical — Product Code FSS

K880540 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "LIGHT, SURGICAL, FLOOR STANDING". The FDA issued a decision of Substantially Equivalent on February 24, 1988. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Ferguson Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1988
Date Received
February 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ferguson Medical

  • K033153 — DICOM THEATER (April 23, 2004)
  • K962615 — TUMORLOCALIZER MRI (March 19, 1998)
  • K963794 — PUNCTURENEEDLE (March 19, 1998)
  • K971813 — EMBLA (January 16, 1998)
  • K972217 — ORTHOPEDIC SCREW SYSTEM (November 20, 1997)
  • K972219 — ORTHOPEDIC PLATE SYSTEM (November 20, 1997)
  • K970819 — TARGOBEAM (July 14, 1997)
  • K970257 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTE (May 22, 1997)
  • K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTE (May 22, 1997)
  • K970258 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMOR (May 22, 1997)

Other clearances for product code FSS

  • K091246 — ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M (September 28, 2009)
  • K003489 — NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT G (February 2, 2001)
  • K984124 — AESCULAP XENON LIGHT SOURCE (February 1, 1999)
  • K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (August 18, 1998)
  • K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (July 29, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980044 — XENON 300MX (April 3, 1998)
  • K970886 — HANAULUX BLUE 80 HOSPITAL (April 16, 1997)
  • K961971 — Q-5000 (June 28, 1996)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)

FDA data resources