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510(k) K823915

MIRROR TIP by Treace Medical, Inc. — Product Code KAI

K823915 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "MIRROR TIP". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code KAI (Mirror, Ent), 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
January 21, 1983
Date Received
December 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mirror, Ent
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 KAI

  • K833601 — ANTRUM & ATTIC MIRROR (January 3, 1984)
  • K822374 — BUCKINGHAM ATTIC & ANTRUM MIRROR (September 9, 1982)
  • K822261 — LARYNGEAL MIRRORS (August 30, 1982)
  • K822191 — HEAD MIRROR WITH HEADBAND (August 20, 1982)
  • K820354 — ATMOS MIRROR WARMER (March 1, 1982)
  • K781750 — MIRROR WARMER (January 17, 1979)
  • K770053 — MIRROR, LARYNGEAL (January 18, 1977)
  • K770054 — MIRROR, NASO-PHARYNX (January 18, 1977)

FDA data resources