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510(k) K870761

EAR LOOP by Treace Medical, Inc. — Product Code JYQ

K870761 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "EAR LOOP". The FDA issued a decision of Substantially Equivalent on March 3, 1987. The device falls under product code JYQ (Loop, Wire), a Class I device regulated under 21 CFR 874.4420. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Loop, Wire
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
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)
  • K870765 — CANNULATED INSTRUMENT CLEANERS (May 27, 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)

Other clearances for product code JYQ

  • K890221 — MICROSURGICAL WIRE LOOP (January 27, 1989)

FDA data resources