Home / 510(k) Clearances / K844759

510(k) K844759

SURGICAL SCALPEL BLADES & DISPOSABLES by Cross Country Paper Products Corp. — Product Code GES

K844759 is an FDA 510(k) premarket notification submitted by Cross Country Paper Products Corp. for the device "SURGICAL SCALPEL BLADES & DISPOSABLES". The FDA issued a decision of Substantially Equivalent on January 18, 1985. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Cross Country Paper Products Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1985
Date Received
December 7, 1984
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 Cross Country Paper Products Corp.

  • K941327 — CROSSTEX SELF-SEALING STERILIZATION POUCH (December 22, 1994)
  • K861727 — COTTON FILLED GAUZE SPONGES 2 X 2 (July 10, 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