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510(k) K822369

MICRO & MINI-MICRO ALLIGATOR FORCEPS by Treace Medical, Inc. — Product Code KAE

K822369 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "MICRO & MINI-MICRO ALLIGATOR FORCEPS". The FDA issued a decision of Substantially Equivalent on September 9, 1982. The device falls under product code KAE (Forceps, 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
September 9, 1982
Date Received
August 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, 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 KAE

  • K853708 — LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE (February 14, 1986)
  • K851795 — 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS (June 11, 1985)
  • K851775 — 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS (June 11, 1985)
  • K851794 — 41-180 TO 41-246 VARIOUS NASAL FORCEPS (June 11, 1985)
  • K833608 — GOLD ALLIGATOR FORCEPS (January 11, 1984)
  • K833605 — CUPPED FORCEPS (January 3, 1984)
  • K833607 — MCGEE FORCEPS (January 3, 1984)
  • K822372 — OFFICE ECONO-FORCEPS (September 9, 1982)
  • K812895 — YARMO NASAL CARTILAGE SOFTENER (November 2, 1981)
  • K772377 — HILDYARD POST NASAL FORCEP (January 17, 1978)

FDA data resources