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510(k) K022743

REPROCESSED DISPOSABLE TROCARS by Medical Device Services — Product Code KAB

K022743 is an FDA 510(k) premarket notification submitted by Medical Device Services for the device "REPROCESSED DISPOSABLE TROCARS". The FDA issued a decision of Substantially Equivalent on October 9, 2002. The device falls under product code KAB (Trocar, Laryngeal), a Class I device regulated under 21 CFR 874.4420. Medical Device Services has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2002
Date Received
August 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Laryngeal
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Medical Device Services

  • K022753 — REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS (November 14, 2002)
  • K022751 — REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS (November 4, 2002)
  • K022748 — REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS (October 9, 2002)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012979 — COMPRESSIBLE LIMB SLEEVE (May 8, 2002)

FDA data resources