Home / 510(k) Clearances / K853528

510(k) K853528

STAINLESS STEEL & CARBON STEEL STERILE BLADES by Abco Dealers, Inc. — Product Code GES

K853528 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "STAINLESS STEEL & CARBON STEEL STERILE BLADES". The FDA issued a decision of Substantially Equivalent on September 24, 1985. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1985
Date Received
August 23, 1985
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 Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 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