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510(k) K822254

ELECTRIC CORD FOR ENDOSCOPE by Kelleher Corp. — Product Code FFZ

K822254 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "ELECTRIC CORD FOR ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on August 20, 1982. The device falls under product code FFZ (Cord, Electric, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1982
Date Received
July 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Electric, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Kelleher Corp.

  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (January 28, 1983)
  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
  • K823111 — NYSTYMOGRAPH ACCESS (November 22, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K822272 — HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (November 10, 1982)
  • K822017 — TYMPANOSTOMY TUBES & VARIOUS TYPES (October 27, 1982)
  • K822257 — VARIOUS TYPES OF LIGHT SOURCE HANDLES (October 26, 1982)
  • K822259 — LARYNGEAL SPATULAS (October 22, 1982)
  • K822004 — FACE SHIELDS (October 20, 1982)

Other clearances for product code FFZ

  • K111013 — ACEM (December 19, 2011)
  • K782046 — C-CORD (January 10, 1979)

FDA data resources