Home / 510(k) Clearances / K934204

510(k) K934204

INTERTIP INFUSION SET by Oasis Medical, Inc. — Product Code HQE

K934204 is an FDA 510(k) premarket notification submitted by Oasis Medical, Inc. for the device "INTERTIP INFUSION SET". The FDA issued a decision of Substantially Equivalent on February 7, 1994. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Oasis Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1994
Date Received
August 30, 1993
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 Oasis Medical, Inc.

  • K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (June 3, 2022)
  • K162361 — Soft Plug Extended Duration 180 Canalicular Plug (April 17, 2017)
  • K032297 — DISPOSABLE N-PE MICKROKERATOME BLADES (August 26, 2003)
  • K030401 — DISPOSABLE M2-PE MICROKERATOME BLADES (June 19, 2003)
  • K022205 — DISPOSABLE N-PE MICROKERATOME BLADES (October 3, 2002)
  • K013613 — SOFT PLUG ABSORBABLE PLUG-SA (June 27, 2002)
  • K003820 — DISPOSABLE CB-PE MICROKERATOME BLADES (March 8, 2001)
  • K001176 — DISPOSABLE MICROKERATOME BLADES-PE (September 21, 2000)
  • K980437 — SILICONE PUNCTAL PLUG (April 30, 1998)
  • K950798 — POSTERIOR CAPSULE SHIELD (May 22, 1995)

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