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510(k) K901677

CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER by Buckman Co., Inc. — Product Code LGH

K901677 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER". The FDA issued a decision of Substantially Equivalent on April 23, 1990. The device falls under product code LGH (Instrument, Cast Removal, Ac-Powered), a Class I device regulated under 21 CFR 888.5960. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1990
Date Received
April 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cast Removal, Ac-Powered
Device Class
Class I
Regulation Number
888.5960
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 LGH

  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K893380 — QCR SYSTEM I AND QCR SYSTEM II (November 16, 1989)
  • K895861 — DELTA-TECH(TM) CAST REMOVAL SYSTEM (October 19, 1989)
  • K873723 — PLASTER VACUUM, 230V MODEL NO. 4183-161 (December 10, 1987)
  • K873721 — PLASTER VACUUM, 115V MODEL NO. 4183-160 (December 7, 1987)
  • K873719 — CAST CUTTER, 115V MODEL NO. 4183-106 (October 2, 1987)
  • K873720 — CAST CUTTER, 230V MODEL NO. 4183-107 (October 2, 1987)
  • K820351 — CAST CUTTER/CAST SAW/INSTRUMENT (March 2, 1982)

FDA data resources