Home / 510(k) Clearances / K945420

510(k) K945420

CHAKOFF ENDOSCOPY by Stephen Chakoff, Inc. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1994
Date Received
November 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Stephen Chakoff, Inc.

  • K940316 — HYSTERSCOPE (November 16, 1995)
  • K940317 — SINUSCOPE (May 24, 1995)
  • K950753 — CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO (May 15, 1995)
  • K951082 — CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE (March 22, 1995)
  • K950748 — CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE) (March 6, 1995)
  • K950747 — CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) (March 6, 1995)
  • K950746 — CHAKOFF ENDOSCOPY (SET LAPAROSCOPY) (March 6, 1995)
  • K950745 — CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES) (March 6, 1995)
  • K950744 — CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE) (March 6, 1995)
  • K945421 — CHAKOFF ENDOSCOPY (December 23, 1994)

Other clearances for product code FCW

  • K131226 — NOVAPROBE LED LIGHT SOURCE (July 24, 2014)
  • K123956 — POWER LED 175 (January 25, 2013)
  • K123359 — OVS1 VIDEO SYSTEM (December 19, 2012)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K093792 — LED LIGHT SOURCE (March 18, 2010)
  • K091968 — KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (September 14, 2009)
  • K082813 — STRYKER LED LIGHTSOURCE (December 19, 2008)
  • K081477 — LUXTEC MLX LIGHT SOURCE (June 18, 2008)
  • K032430 — ACUEITY MEDICAL LIGHT SOURCE (September 5, 2003)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)