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510(k) K870765

CANNULATED INSTRUMENT CLEANERS by Treace Medical, Inc. — Product Code EKW

K870765 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "CANNULATED INSTRUMENT CLEANERS". The FDA issued a decision of Substantially Equivalent on May 27, 1987. The device falls under product code EKW (Broach, Endodontic), a Class I device regulated under 21 CFR 872.4565. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Broach, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Treace Medical, Inc.

  • K883727 — BUCKET PROSTHESIS PORP (January 13, 1989)
  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • K874779 — BIPOLATOR 50 (January 29, 1988)
  • K873154 — TREACE MAGNUM OTO-TOOL SYSTEM (September 4, 1987)
  • K872000 — EYE GARD (July 21, 1987)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)
  • K870760 — BUR BRUSH (March 18, 1987)

Other clearances for product code EKW

  • K871493 — DENTI-TRAY(TM) (June 24, 1987)
  • K862523 — MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS (August 1, 1986)
  • K831749 — ENDODONTIC BROACH(76EKN) BARBED BROACH (July 12, 1983)
  • K823489 — ENDODONTIC BROACH-BARBED BROACH (December 15, 1982)
  • K800292 — ENDEX BROACH, ENDODONTIC (February 19, 1980)
  • K760985 — HAND INSTRUMENTS (November 15, 1976)

FDA data resources