Home / 510(k) Clearances / K070873

510(k) K070873

AMSURE BLADDER IRRIGATION SET by Amsino Intl., Inc. — Product Code LJH

K070873 is an FDA 510(k) premarket notification submitted by Amsino Intl., Inc. for the device "AMSURE BLADDER IRRIGATION SET". The FDA issued a decision of Substantially Equivalent on December 19, 2007. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Amsino Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2007
Date Received
March 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Irrigation, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Amsino Intl., Inc.

  • K992719 — AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE (January 12, 2000)
  • K974042 — AMSURE CLEANSING ENEMA SET (December 19, 1997)
  • K973107 — AMSINO I.V. ADMINISTRATION SET (October 2, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K950780 — AMSINO CERVICAL SCRAPER (July 25, 1995)
  • K951528 — AMSINO DISPOSABLE VIGINAL SPECULUM (May 11, 1995)

Other clearances for product code LJH

  • K162992 — Karl Storz UROMAT E.A.S.I. (July 7, 2017)
  • K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (September 18, 2007)
  • K063700 — SPYGLASS IRRIGATION SYSTEM (February 8, 2007)
  • K062551 — NEXUS IRRIGATION TUBING SET (December 15, 2006)
  • K042457 — URO PRO (October 25, 2004)
  • K040094 — PIGGYBACK IRRIGATING SYSTEM (April 15, 2004)
  • K023808 — IRRIGATION SETS (March 10, 2003)
  • K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (November 28, 2001)
  • K010122 — CONTINUOUS FLOW Y-TUBING (June 4, 2001)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)

FDA data resources