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510(k) K801411

MAY ILLUMINATED/INFUSION PIC by Cooper Medical Devices Corp. — Product Code HMX

K801411 is an FDA 510(k) premarket notification submitted by Cooper Medical Devices Corp. for the device "MAY ILLUMINATED/INFUSION PIC". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Cooper Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
June 16, 1980
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 Cooper Medical Devices Corp.

  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K802927 — SEBESTYEN IRRIGATING CONTACT LENS (February 5, 1981)
  • K801850 — CHARLES PNEUMATIC INTRAOCULAR SCISSORS (September 16, 1980)
  • K801312 — THE PROTECTORS (June 17, 1980)
  • K800833 — VABRA ASPIRATOR (May 14, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)

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)
  • 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)

FDA data resources