Home / 510(k) Clearances / K022823

510(k) K022823

VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 by Geister Medizin Technik GmbH — Product Code MGZ

K022823 is an FDA 510(k) premarket notification submitted by Geister Medizin Technik GmbH for the device "VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520". The FDA issued a decision of Substantially Equivalent on July 1, 2004. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. Geister Medizin Technik GmbH has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2004
Date Received
August 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valvulotome
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type

Other clearances by Geister Medizin Technik GmbH

  • K242759 — Geister K-Rex rongeurs (June 6, 2025)
  • K180610 — Geister retractor for neuro - and spine surgery (August 29, 2018)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K982365 — ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO V (April 8, 1999)
  • K933699 — GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS (January 27, 1994)

Other clearances for product code MGZ

  • K260188 — LimFlow Vector (March 18, 2026)
  • K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (July 3, 2025)
  • K221902 — LimFlow Vector (December 21, 2022)
  • K190267 — EZE SIT Valvulotome (October 30, 2019)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)
  • K132047 — LEMILLS VALVULOTOME (November 5, 2013)
  • K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (August 5, 2013)
  • K111884 — OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (July 29, 2011)
  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)

FDA data resources