Home / 510(k) Clearances / K771045

510(k) K771045

BLADES, SCALPEL by American Safety Razor Co. — Product Code GES

K771045 is an FDA 510(k) premarket notification submitted by American Safety Razor Co. for the device "BLADES, SCALPEL". The FDA issued a decision of Substantially Equivalent on June 22, 1977. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. American Safety Razor Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1977
Date Received
June 10, 1977
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 American Safety Razor Co.

  • K924503 — PERSONNA SAFETY SCALPEL (February 5, 1993)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)
  • K863557 — BLADE, SURGICAL PREPARATION RAZOR, STRAIGHT,SINGLE (October 6, 1986)

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