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510(k) K873162

VAN DELLEN RETROBULBAR NEEDLE by Van Dellen, Ltd. — Product Code HMX

K873162 is an FDA 510(k) premarket notification submitted by Van Dellen, Ltd. for the device "VAN DELLEN RETROBULBAR NEEDLE". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Van Dellen, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
August 11, 1987
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 Van Dellen, Ltd.

  • K873465 — VAN DELLEN BACTERIA FILTER (January 20, 1988)
  • K873464 — VAN DELLEN CANNULA (November 23, 1987)
  • K873463 — VAN DELLEN ASPIRATING TUBING (November 23, 1987)
  • K873462 — VAN DELLEN ASPIRATOR (September 25, 1987)
  • K873163 — VAN DELLEN IRRIGATING CYSTOTOME (September 4, 1987)
  • K873164 — VAN DELLEN HEALON CANNULA (September 4, 1987)

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