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510(k) K875030

OCU-1 by Rudolph Beaver, Inc. — Product Code HMX

K875030 is an FDA 510(k) premarket notification submitted by Rudolph Beaver, Inc. for the device "OCU-1". The FDA issued a decision of Substantially Equivalent on May 3, 1988. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Rudolph Beaver, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1988
Date Received
December 7, 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 Rudolph Beaver, Inc.

  • K883361 — ARTHRO-TRAC(TM) (October 13, 1988)
  • K862709 — MECHANICAL CYSTITOME (August 1, 1986)
  • K860305 — BEAVER MICRO-GEM GAUGE BLOCK (February 12, 1986)
  • K852828 — BEAVER R-K KNIFE (November 4, 1985)
  • K853129 — BEAVER MULTIPURPOSE SAPPHIRE KNIFE (August 6, 1985)

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