Home / 510(k) Clearances / K063234

510(k) K063234

ON-Q INTRODUCERS by I-Flow Corp. — Product Code BSO

K063234 is an FDA 510(k) premarket notification submitted by I-Flow Corp. for the device "ON-Q INTRODUCERS". The FDA issued a decision of Substantially Equivalent on November 21, 2006. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. I-Flow Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2006
Date Received
October 25, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

Other clearances by I-Flow Corp.

  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K063530 — ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, (January 26, 2007)
  • K051401 — ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER (November 30, 2005)
  • K052117 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) (September 9, 2005)
  • K043456 — MODIFICATION TO SOAKER CATHETER (January 11, 2005)
  • K040337 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) (May 24, 2004)
  • K023883 — HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO (December 20, 2002)
  • K023827 — PARAGON INFUSION SYSTEM WITH BOLUS (December 13, 2002)
  • K023318 — I-FLOW ELASTOMERIC PUMP WITH BOLUS (October 18, 2002)
  • K022869 — SOAKER CATHETER (September 20, 2002)

Other clearances for product code BSO

  • K241410 — EDEN ControlCath (February 13, 2025)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Nex (August 30, 2023)
  • K193664 — SubQKath Catheter and Needle Set (September 9, 2020)
  • K200624 — Percutaneous Introducer (April 27, 2020)
  • K191470 — C-CAT Anaesthesia Catheter kit (October 25, 2019)
  • K181782 — Medline Reinforced Epidural Catheter (March 4, 2019)
  • K173541 — EPINAUT (August 24, 2018)
  • K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (May 3, 2018)
  • K171584 — B. Braun Tear-Away Introducer Needle (December 22, 2017)

FDA data resources