Home / 510(k) Clearances / K060933

510(k) K060933

SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM by Apex Medical Technologies, Inc. — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2006
Date Received
April 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Apex Medical Technologies, Inc.

  • K112165 — RHEA CUP (May 24, 2012)
  • K954791 — SEMINAL FLUID COLLECTION KIT II (January 5, 1996)
  • K922688 — EXTRA PROTECTION POLYURETHANE CONDOM (May 4, 1995)
  • K930313 — APEX SPECIMEN BAG (March 18, 1993)
  • K902936 — POLYURETHANE CONDOM (March 6, 1991)
  • K871358 — SENSATIONS BRAND CONDOMS (March 1, 1989)
  • K874539 — HI-TOUCH (TM) BRAND SURGICAL GLOVES (December 14, 1987)

Other clearances for product code MEB

  • K240624 — InfuLife (November 5, 2024)
  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K151650 — SMARTez elastomeric infusion pump (April 4, 2016)
  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)