Home / 510(k) Clearances / K890448

510(k) K890448

LIGHT SOURCE, ENDOSCOP, XENON ARC by Mira, Inc. — Product Code FFS

K890448 is an FDA 510(k) premarket notification submitted by Mira, Inc. for the device "LIGHT SOURCE, ENDOSCOP, XENON ARC". The FDA issued a decision of Substantially Equivalent on May 8, 1989. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Mira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1989
Date Received
January 27, 1989
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 Mira, Inc.

  • K951728 — SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE (March 19, 1997)
  • K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (June 5, 1996)
  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (January 25, 1994)
  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K894248 — CONVERTER SYSTEM (February 27, 1990)
  • K891601 — POWER OPERATED AND CONTROLLED VITREOUS SCISSORS (May 23, 1989)
  • K863246 — MIRALITE (October 31, 1986)
  • K863591 — ENDOPHOTOCOAGULATION PROBE (October 10, 1986)
  • K855105 — SIMMONS SHELL (March 31, 1986)

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