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510(k) K900266

STERILE CARBON STEEL SURGICAL BLADE by Rahn Laboratories — Product Code GES

K900266 is an FDA 510(k) premarket notification submitted by Rahn Laboratories for the device "STERILE CARBON STEEL SURGICAL BLADE". The FDA issued a decision of Substantially Equivalent on March 1, 1990. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Rahn Laboratories has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1990
Date Received
January 18, 1990
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 Rahn Laboratories

  • K892461 — NON-STERILE LATEX EXAMINATION GLOVES (July 28, 1989)
  • K881479 — OPERATION ROOM TOWEL (April 14, 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)
  • 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)
  • K873142 — PERSONNA DISPOSABLE SCALPEL (September 4, 1987)

FDA data resources