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510(k) K821818

RETRIEVAL BALLOONS by American Endoscopy, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1982
Date Received
June 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by American Endoscopy, Inc.

  • K853274 — AMERICAN DILATATION SYSTEM (October 17, 1985)
  • K841384 — PROXIMA 1 PH MONITOR (July 19, 1984)
  • K833491 — ENDO BITE BLOCK (April 25, 1984)
  • K840818 — BIOPSY FORCEPS (April 13, 1984)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K833492 — PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (November 29, 1983)
  • K832458 — AUTOMATIC ENDOSCOPE (October 20, 1983)
  • K821819 — PIGTAIL STENTS (August 20, 1982)
  • K822062 — BALL TIP COAGULATING ELECTRODES (August 19, 1982)
  • K821817 — PIGTAIL NASAL CATHETERS (August 10, 1982)

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  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)