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510(k) K942403

INFUSION CANNULA by Microsurgical Technology, Inc. — Product Code HMX

K942403 is an FDA 510(k) premarket notification submitted by Microsurgical Technology, Inc. for the device "INFUSION CANNULA". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Microsurgical Technology, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
May 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Microsurgical Technology, Inc.

  • K953959 — PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO (November 17, 1995)
  • K946194 — WEE BAG O'MERCURY (February 27, 1995)
  • K943672 — PHACO NEEDLES AND TIPS (October 13, 1994)
  • K934844 — INTER TIP T (April 19, 1994)
  • K854402 — THE NEW MCINTYRE I.A. HANDPIECE (December 30, 1985)
  • K854401 — THE NEW MOBILE TIP MCINTYRE CANNULA (December 30, 1985)
  • K853777 — THE NEW MCINTYRE CANNULA (November 21, 1985)
  • K840442 — STERILIZED DISPOS. CYSTOTOME (March 16, 1984)

Other clearances for product code HMX

  • K010305 — WEISS RETINAL CANNULA (May 2, 2001)
  • K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAM (May 9, 2000)
  • K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (May 20, 1997)
  • K943932 — STERISEAL OPHTHALMIC CANNULA (January 18, 1995)
  • K934844 — INTER TIP T (April 19, 1994)
  • K930113 — KIRWAN IRRIGATION/ASPIRATION HANDPIECE (February 17, 1994)
  • K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (May 7, 1992)
  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)
  • K901618 — OCULAR INFUSION CANNULA SYSTEM (May 31, 1990)

FDA data resources