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510(k) K873493

NINJA SCALPEL by Primrose Medical, Inc. — Product Code GES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1987
Date Received
August 31, 1987
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 Primrose Medical, Inc.

  • K884715 — ACHELASIA BALLOON DIALATOR (September 29, 1989)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K884714 — BILIARY DIALATOR (September 29, 1989)
  • K884711 — URETHRAL AND URETERAL BALLOON DILATATORS (September 29, 1989)
  • K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (September 8, 1989)
  • K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (September 8, 1989)
  • K883420 — LANCET, BLOOD (August 26, 1988)
  • K881976 — CATHETER, INTRAVASCULAR (August 4, 1988)
  • K881977 — PRESSURE INFUSOR (July 29, 1988)
  • K881975 — SET, INTRAVASCULAR (July 29, 1988)

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)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)