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510(k) K944688

LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR by Progressive Dynamics, Inc. — Product Code FFS

K944688 is an FDA 510(k) premarket notification submitted by Progressive Dynamics, Inc. for the device "LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on November 1, 1994. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Progressive Dynamics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1994
Date Received
September 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Progressive Dynamics, Inc.

  • K952329 — LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM (January 17, 1996)
  • K933764 — LIFE-AIR 1000 PATIENT WARMING COVER (November 9, 1993)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K921866 — LUMINOUS 250 FIBEROPTIC ILLUMINATOR (July 8, 1992)
  • K914382 — LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM (April 21, 1992)
  • K914383 — LIFE-AIR 1000 PATIENT WARMING COVERS (March 30, 1992)

Other clearances for product code FFS

  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061622 — PS SERIES (March 5, 2007)
  • K063309 — TRU-CABLE (January 12, 2007)
  • K061025 — ACCUTECH ENDOLITE PROBE (May 31, 2006)
  • K023633 — SOVIS OPTIQUE'S ENDOSCOPIC CABLE (December 31, 2002)
  • K001698 — MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (July 17, 2000)
  • K994084 — SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (January 20, 2000)
  • K991323 — SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (July 6, 1999)
  • K983714 — SOLARTEC SOURCE 270, MODEL # 90123 (December 23, 1998)
  • K982462 — FIBER OPTIC ENDOILLUMINATION PROBE (September 14, 1998)

FDA data resources