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510(k) K870779

ACROMED WALLIE-HEINIG TROCHAR by Buckman Co., Inc. — Product Code HWJ

K870779 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED WALLIE-HEINIG TROCHAR". The FDA issued a decision of Substantially Equivalent on March 9, 1987. The device falls under product code HWJ (Awl), a Class I device regulated under 21 CFR 888.4540. 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
Awl
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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 HWJ

  • K895587 — CROSS MEDICAL PRODUCT PEDICLE AWL (January 4, 1990)
  • K880045 — ACROMED AWL/PUNCH, DEPTH GAUGE (February 17, 1988)
  • K875223 — DANNINGER ORTHOPAEDIC AWL (February 17, 1988)

FDA data resources