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510(k) K822201

EAR CANNULAS by Kelleher Corp. — Product Code FGY

K822201 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "EAR CANNULAS". The FDA issued a decision of Substantially Equivalent on October 6, 1982. The device falls under product code FGY (Cannula, Injection), a Class I device regulated under 21 CFR 878.4200. Kelleher Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1982
Date Received
July 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Injection
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Kelleher Corp.

  • K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
  • K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (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 FGY

  • K760389 — CANNULA, IV (November 2, 1976)

FDA data resources