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510(k) K851157

SURGIMED - SURGICAL BLADES by Surgimed Corp. — Product Code GES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1985
Date Received
March 22, 1985
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 by Surgimed Corp.

  • K062753 — FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC (February 8, 2007)
  • K840762 — SILVERTORQUE CEREBRAL CATHETER (July 13, 1984)
  • K840763 — SILVERTORQUE CARDIAC CATHETERS (June 13, 1984)
  • K840761 — SILVERTORQUE VISCERAL CATHETER (June 11, 1984)
  • K810689 — BALLOON CATHETER (July 28, 1981)

Other clearances for product code GES

  • K032242 — PERSONNA PLUS SAFETY SCALPEL SYSTEM (September 23, 2003)
  • K932998 — EASY-ON (August 18, 1993)
  • K923170 — LOS ALAMOS RETRACTABLE KNIFE (February 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)