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510(k) K910328

KEY COMFORT GRIPS by Key Surgical, Inc. — Product Code FSM

K910328 is an FDA 510(k) premarket notification submitted by Key Surgical, Inc. for the device "KEY COMFORT GRIPS". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Key Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
January 25, 1991
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 Key Surgical, Inc.

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K151222 — Cautery Tip Cleaner (May 22, 2015)
  • K896676 — KEY VASCULAR LOOPS (February 27, 1990)
  • K896472 — KEY VASCULAR BOOTIES (December 14, 1989)
  • K895591 — SILICONE INSTRUMENT SHODS (October 20, 1989)

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)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)

FDA data resources