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510(k) K063309

TRU-CABLE by Truphatek International, Ltd. — Product Code FFS

K063309 is an FDA 510(k) premarket notification submitted by Truphatek International, Ltd. for the device "TRU-CABLE". The FDA issued a decision of Substantially Equivalent on January 12, 2007. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Truphatek International, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2007
Date Received
November 2, 2006
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 Truphatek International, Ltd.

  • K062523 — TRU-MR LARYNGOSCOPE SET (November 17, 2006)

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)
  • 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)
  • K980636 — FIBER OPTIC ENDOILLUMINATION PROBE (May 20, 1998)

FDA data resources