Home / 510(k) Clearances / K950267

510(k) K950267

URETHRAL SUTURE GUIDE by Applied Medical Resources — Product Code KOA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1995
Date Received
January 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
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 KOA

  • K182664 — FiXcision (December 7, 2018)
  • K932465 — LI VASECTOMY (March 2, 1994)
  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (October 5, 1992)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)