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510(k) K923170

LOS ALAMOS RETRACTABLE KNIFE by Innovative Surgical Technology, Inc. — Product Code GES

K923170 is an FDA 510(k) premarket notification submitted by Innovative Surgical Technology, Inc. for the device "LOS ALAMOS RETRACTABLE KNIFE". The FDA issued a decision of Substantially Equivalent on February 18, 1993. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1993
Date Received
June 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code GES

  • K032242 — PERSONNA PLUS SAFETY SCALPEL SYSTEM (September 23, 2003)
  • K932998 — EASY-ON (August 18, 1993)
  • K915119 — SCALPEL BLADE REMOVER (BLADEGARD) (May 5, 1992)
  • K911913 — PRECISION GLIDE - ENHANCED SURGICAL BLADE (May 13, 1991)
  • K900266 — STERILE CARBON STEEL SURGICAL BLADE (March 1, 1990)
  • K884862 — ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (December 27, 1988)
  • K881638 — SURGICAL BLADE (June 15, 1988)
  • K880244 — SURGICAL BLADES (February 10, 1988)
  • K873493 — NINJA SCALPEL (September 24, 1987)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)

FDA data resources