Home / 510(k) Clearances / K922919

510(k) K922919

DYNACYT BIOPSY ASPIRATION DEVICE by Buckman Co., Inc. — Product Code MJG

K922919 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "DYNACYT BIOPSY ASPIRATION DEVICE". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code MJG (Device, Percutaneous, Biopsy), 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 31, 1993
Date Received
June 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous, Biopsy
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 MJG

  • K080674 — PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (May 9, 2008)
  • K070836 — EXICLIP EXCS-M (April 20, 2007)
  • K983647 — ECHO-COAT ULTRASOUND NEEDLES (January 20, 1999)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)
  • K933324 — SKIN BIOPSY DEVICE (March 31, 1994)
  • K925870 — SPACER (May 19, 1993)

FDA data resources