Home / 510(k) Clearances / K863885

510(k) K863885

SABLE BLADES by Sable Industries — Product Code GES

K863885 is an FDA 510(k) premarket notification submitted by Sable Industries for the device "SABLE BLADES". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Sable Industries has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
October 6, 1986
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 Sable Industries

  • K083101 — PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES (February 23, 2009)
  • K072554 — ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES (November 14, 2007)

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)

FDA data resources