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510(k) K831584

BAILEY ASPIRATOR/IRRIGATOR by Medical Instrument Development Laboratories, Inc. — Product Code HQE

K831584 is an FDA 510(k) premarket notification submitted by Medical Instrument Development Laboratories, Inc. for the device "BAILEY ASPIRATOR/IRRIGATOR". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Medical Instrument Development Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
May 17, 1983
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 Medical Instrument Development Laboratories, Inc.

  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)
  • K992943 — VIT ENHANCER (December 10, 1999)
  • K971067 — DIGI-INJECTOR (September 19, 1997)
  • K950287 — UNIVIT PROBE (April 10, 1995)
  • K934600 — MICRODRIVE (July 27, 1994)
  • K932669 — SUPRA-VIT(TM) (June 3, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K924222 — MID LABS, INC. VIT MATE (January 27, 1993)

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