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510(k) K870781

ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS by Buckman Co., Inc. — Product Code GEG

K870781 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS". The FDA issued a decision of Substantially Equivalent on March 9, 1987. The device falls under product code GEG (Elevator, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Buckman Co., Inc.

  • K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM (June 25, 1998)
  • K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM (June 8, 1998)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (January 16, 1997)
  • K960451 — WEBB-MORLEY SPINE SYSTEM (April 18, 1996)
  • K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS (January 25, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (October 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)

Other clearances for product code GEG

  • K891894 — ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE (April 12, 1989)
  • K891899 — ELEVATORS, VARIOUS TYPES (April 12, 1989)
  • K890365 — SEPTUM ELEVATOR (February 3, 1989)
  • K890230 — LIGATURE NEEDLES (January 27, 1989)
  • K890253 — SURGICAL ELEVATOR (January 27, 1989)
  • K872491 — 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS (July 16, 1987)
  • K870591 — ELEVATOR, COBB SPINAL (February 26, 1987)
  • K870126 — FEMUR WRENCH (February 3, 1987)
  • K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORS (November 26, 1986)
  • K834176 — H.R. JAKOBI SURG. INSTRUMENTS 40/41 (January 27, 1984)

FDA data resources