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510(k) K930113

KIRWAN IRRIGATION/ASPIRATION HANDPIECE by Kirwan Surgical Products, Inc. — Product Code HMX

K930113 is an FDA 510(k) premarket notification submitted by Kirwan Surgical Products, Inc. for the device "KIRWAN IRRIGATION/ASPIRATION HANDPIECE". The FDA issued a decision of Substantially Equivalent on February 17, 1994. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Kirwan Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1994
Date Received
January 11, 1993
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 Kirwan Surgical Products, Inc.

  • K231872 — Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module ( (August 25, 2023)
  • K100912 — DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULA (August 19, 2010)
  • K070360 — KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-36 (August 7, 2007)
  • K060915 — KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APP (April 17, 2007)
  • K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (March 9, 2007)
  • K052203 — AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 (October 20, 2005)
  • K023482 — AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 (January 15, 2003)
  • K992218 — DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-46 (July 30, 1999)
  • K982176 — KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR (September 18, 1998)
  • K971341 — KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR (May 22, 1997)

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)
  • K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (May 7, 1992)
  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)
  • K901618 — OCULAR INFUSION CANNULA SYSTEM (May 31, 1990)

FDA data resources