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510(k) K895861

DELTA-TECH(TM) CAST REMOVAL SYSTEM by Johnson & Johnson Professionals, Inc. — Product Code LGH

K895861 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "DELTA-TECH(TM) CAST REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 1989. The device falls under product code LGH (Instrument, Cast Removal, Ac-Powered), a Class I device regulated under 21 CFR 888.5960. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1989
Date Received
October 3, 1989
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 Johnson & Johnson Professionals, Inc.

  • K992173 — SIPHONGUARD CSF CONTROL DEVICE (April 7, 2000)
  • K991413 — CODMAN ETHISORB DURA PATCH (March 13, 2000)
  • K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT (July 9, 1999)
  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) (December 4, 1998)
  • K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (November 6, 1998)
  • K983014 — SUMMIT ACETABULAR SYSTEM (October 27, 1998)
  • K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (July 17, 1998)
  • K974739 — HAKIM PROGRAMMABLE VALVE SYSTEM (July 1, 1998)
  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

Other clearances for product code LGH

  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K901677 — CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (April 23, 1990)
  • K893380 — QCR SYSTEM I AND QCR SYSTEM II (November 16, 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