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510(k) K932653

SWISSTEK 2000(TM) CAST REMOVAL SYSTEM by Carapace, Inc. — Product Code LGH

K932653 is an FDA 510(k) premarket notification submitted by Carapace, Inc. for the device "SWISSTEK 2000(TM) CAST REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code LGH (Instrument, Cast Removal, Ac-Powered), a Class I device regulated under 21 CFR 888.5960. Carapace, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
June 2, 1993
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 Carapace, Inc.

  • K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
  • K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
  • K931729 — I.V. START KIT (February 22, 1994)
  • K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
  • K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
  • K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
  • K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
  • K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
  • K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)
  • K931670 — CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS (January 25, 1994)

Other clearances for product code LGH

  • K901677 — CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (April 23, 1990)
  • 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