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510(k) K914221

KPE 220 TS, NONSTERILE by Ipax, Inc. — Product Code HQE

K914221 is an FDA 510(k) premarket notification submitted by Ipax, Inc. for the device "KPE 220 TS, NONSTERILE". The FDA issued a decision of Substantially Equivalent on October 25, 1991. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Ipax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1991
Date Received
August 23, 1991
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 Ipax, Inc.

  • K200893 — ProntoPump Sterile Tube Set (May 4, 2021)
  • K971242 — BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (December 17, 1997)
  • K971245 — BLINK EXTERNAL EYELID WEIGHT (June 20, 1997)
  • K915158 — SUREBREATH DOME, E-Z BREATHER (February 12, 1992)
  • K915118 — PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE (December 27, 1991)
  • K914172 — KPE 230 AM (October 25, 1991)
  • K884076 — SUREBREATH DOME (October 7, 1988)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K870770 — TIMLEINE(TM) VENIPUNCTURE SYSTEM (April 23, 1987)
  • K864726 — I/A/KPE TIP (January 20, 1987)

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