Home / 510(k) Clearances / K853382

510(k) K853382

MAID MENTOR ASPIRATION/IRRIGATION DEVRO by Mentor O & O, Inc. — Product Code HQE

K853382 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "MAID MENTOR ASPIRATION/IRRIGATION DEVRO". The FDA issued a decision of Substantially Equivalent on October 4, 1985. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Mentor O & O, Inc.

  • K955245 — MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM (February 12, 1996)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K912904 — MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM (June 11, 1992)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K910637 — MENTOR(R) SUR-E-TROL(R) (May 13, 1991)
  • K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 (May 2, 1991)
  • K903878 — MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT (November 5, 1990)
  • K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (September 11, 1989)
  • K890622 — SURG-E-TROL SYSTEM I AND SYSTEM II (May 4, 1989)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)

FDA data resources