Home / 510(k) Clearances / K962328

510(k) K962328

SINGLE USE INSTRUMENT TRAY by Medcare Medical Group, Inc. — Product Code FSM

K962328 is an FDA 510(k) premarket notification submitted by Medcare Medical Group, Inc. for the device "SINGLE USE INSTRUMENT TRAY". The FDA issued a decision of Substantially Equivalent on August 9, 1996. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Medcare Medical Group, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1996
Date Received
June 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Medcare Medical Group, Inc.

  • K973497 — HUBERLOC (January 13, 1998)
  • K970152 — BIOPSY TRAY (March 5, 1997)
  • K962849 — CATHETER INSERTION TRAY (October 7, 1996)
  • K961075 — MEDCARE REGIONAL ANETHESIA KIT (September 6, 1996)
  • K962527 — GENERAL PURPOSE DENTAL TRAY (August 1, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K961167 — MEDCARE TRACHEOSTOMY CARE TRAY (July 2, 1996)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)
  • K912106 — ARTHROSCOPY TRAY (August 29, 1991)
  • K912053 — OPEN HEART TRAY (August 26, 1991)
  • K912052 — HEART CATH TRAY (August 20, 1991)
  • K912104 — MAJOR BASIN TRAY (August 9, 1991)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)

FDA data resources