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510(k) K880244

SURGICAL BLADES by Ailee C/O Havel'S, Inc. — Product Code GES

K880244 is an FDA 510(k) premarket notification submitted by Ailee C/O Havel'S, Inc. for the device "SURGICAL BLADES". The FDA issued a decision of Substantially Equivalent on February 10, 1988. 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 10, 1988
Date Received
January 20, 1988
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)
  • 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)
  • K873493 — NINJA SCALPEL (September 24, 1987)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)

FDA data resources