Home / 510(k) Clearances / K971498

510(k) K971498

APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE by Applied Medical Resources — Product Code EZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1997
Date Received
April 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet For Catheter, Gastro-Urology
Device Class
Class I
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Applied Medical Resources

  • K252740 — Voyant® Open Fusion Device (EB240/Open Fusion) (November 4, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)
  • K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (October 2, 2025)
  • K200021 — Applied Medical Anoscope (January 6, 2021)
  • K201212 — Voyant Open Fusion Device (June 5, 2020)
  • K200598 — Voyant Maryland Fusion Device (April 8, 2020)
  • K193292 — Voyant 5mm Fusion Device, Voyant Maryland Fusion Device (December 20, 2019)
  • K191294 — Transvaginal Access Platform (September 6, 2019)
  • K182653 — Voyant Maryland Fusion Device (November 14, 2018)
  • K182244 — Voyant Electrosurgical Generator (October 11, 2018)

Other clearances for product code EZB

  • K970994 — CORE AND COIL ASSEMBLY GUIDEWIRE (March 25, 1997)
  • K874164 — GUIDE WIRE (December 7, 1987)