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510(k) K904231

MODEL OSP, SANDHILL AMS by Sandhill Scientific, Inc. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1991
Date Received
August 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by Sandhill Scientific, Inc.

  • K111013 — ACEM (December 19, 2011)
  • K012232 — INSIGHT, MODEL S980000 (June 7, 2002)
  • K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE (February 28, 2002)
  • K002427 — SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (June 22, 2001)
  • K990441 — INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 (May 12, 1999)
  • K984444 — INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 (January 11, 1999)
  • K961056 — BIOVIEW MODEL S960000 (June 6, 1996)
  • K942247 — SMALL BOWEL ANALYSIS SOFTWARE (April 9, 1996)
  • K941801 — ANALGRAPH (September 8, 1995)
  • K931963 — SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (September 28, 1994)

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  • K232920 — RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent (March 22, 2024)
  • K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima AP (November 10, 2022)
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  • K213444 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Ki (March 17, 2022)
  • K213186 — NovoFlow Reinforced Ureteral Stent (February 16, 2022)