Home / 510(k) Clearances / K915074

510(k) K915074

IRRIGATOR/ASPIRATOR PROBE by Biomedical Dynamics, Inc. — Product Code HMX

K915074 is an FDA 510(k) premarket notification submitted by Biomedical Dynamics, Inc. for the device "IRRIGATOR/ASPIRATOR PROBE". The FDA issued a decision of Substantially Equivalent on February 5, 1992. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Biomedical Dynamics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1992
Date Received
November 8, 1991
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 Biomedical Dynamics, Inc.

  • K913751 — PRESSURE INFUSER (January 9, 1992)
  • K911213 — CUFFABLE (August 7, 1991)
  • K911216 — INFUSABLE (July 22, 1991)
  • K911324 — IRRIGATION/ASPIRATION TUBING SET (June 24, 1991)
  • K904376 — ANEROID BLOOD PRESSURE GAUGE (December 20, 1990)
  • K890268 — PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION (May 5, 1989)
  • K881799 — BLOOD PRESSURE CUFF (October 14, 1988)
  • K861977 — BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR (July 15, 1986)
  • K850506 — CORRECT FLO INTRAVASCULAR ADMINISTRATION SET (April 1, 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)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)
  • K901618 — OCULAR INFUSION CANNULA SYSTEM (May 31, 1990)

FDA data resources