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510(k) K010305

WEISS RETINAL CANNULA by Micron Surgical, Inc. — Product Code HMX

K010305 is an FDA 510(k) premarket notification submitted by Micron Surgical, Inc. for the device "WEISS RETINAL CANNULA". The FDA issued a decision of Substantially Equivalent on May 2, 2001. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2001
Date Received
February 1, 2001
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 for product code HMX

  • 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)
  • K942403 — INFUSION CANNULA (August 17, 1994)
  • 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