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510(k) K831532

OCULAR IRRIGATING CANNULA by Dey Laboratories, Inc. — Product Code HMX

K831532 is an FDA 510(k) premarket notification submitted by Dey Laboratories, Inc. for the device "OCULAR IRRIGATING CANNULA". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Dey Laboratories, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
May 13, 1983
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 Dey Laboratories, Inc.

  • K972778 — DEY VIAL SODIUM CHLORIDE 3% (October 8, 1997)
  • K910239 — NEBU-SOL METERED DOSE DISPENSER (TM) (May 22, 1991)
  • K880411 — DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE (February 29, 1988)
  • K875011 — DEY-PAK PURIFIED WATER, USP, STERILE (January 22, 1988)
  • K875024 — DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP (January 22, 1988)

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