Home / 510(k) Clearances / K822618

510(k) K822618

EMERGENCY TRACHEOSTOMY INSTRUMENT SET by Kelleher Corp. — Product Code LJW

K822618 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "EMERGENCY TRACHEOSTOMY INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on January 28, 1983. The device falls under product code LJW (Tracheotome), a Class I device regulated under 21 CFR 874.4420. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1983
Date Received
September 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tracheotome
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Kelleher Corp.

  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
  • K822252 — ENT TREATMENT UNITS (November 22, 1982)
  • K823111 — NYSTYMOGRAPH ACCESS (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)
  • K822185 — LARYNGEAL SYRINGE (October 18, 1982)

Other clearances for product code LJW

  • K933570 — RESOLUTION(TM) HIP STEM (March 7, 1994)

FDA data resources