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510(k) K882295

FILLING VOLUME OPTION by Eris Medical Technology — Product Code LJH

K882295 is an FDA 510(k) premarket notification submitted by Eris Medical Technology for the device "FILLING VOLUME OPTION". The FDA issued a decision of Substantially Equivalent on September 13, 1988. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. Eris Medical Technology has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1988
Date Received
June 2, 1988
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 Eris Medical Technology

  • K881878 — CATHETER WITHDRAWAL UNIT (July 28, 1988)
  • K850169 — ERIS URO-DIAGNOSTIC SYSTEM (April 22, 1985)

Other clearances for product code LJH

  • K254111 — Irrigation/Urology Sets (September 10, 2026)
  • K162992 — Karl Storz UROMAT E.A.S.I. (July 7, 2017)
  • K070873 — AMSURE BLADDER IRRIGATION SET (December 19, 2007)
  • 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)

FDA data resources