Home / 510(k) Clearances / K760428

510(k) K760428

SUTURE RACK & NEEDLE COUNTER by Kleen Test Products — Product Code FSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1976
Date Received
August 13, 1976
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 Kleen Test Products

  • K890039 — KLEEN TEST BASIN SET (October 24, 1989)
  • K890539 — SURE COUNT LIGHT HANDLE COVER (February 27, 1989)
  • K890098 — KLEEN TEST O.R. KIT (January 24, 1989)
  • K853622 — SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 (October 10, 1985)
  • K853454 — SURE COUNT 5 & 10 SPONGE COUNTER (September 5, 1985)
  • K853315 — CAUTERY TIP CLEANING PAD (August 21, 1985)
  • K852258 — SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER (June 27, 1985)
  • K852257 — SURE-COUNT 15 COUNT NEEDLE COUNTER (June 26, 1985)
  • K844199 — ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET (November 7, 1984)
  • K821396 — OUT-RITE WASTE DISPOSABLE BAG (June 9, 1982)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • 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)