Home / 510(k) Clearances / K232370

510(k) K232370

Percutaneous Nephroscope System by Karl Storz SE & CO. KG — Product Code FGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2024
Date Received
August 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Nephroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Karl Storz SE & CO. KG

  • K260003 — KARL STORZ Mediastinoscopes and Instruments (March 2, 2026)
  • K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens (February 26, 2026)
  • K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (February 12, 2026)
  • K251731 — KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (December 5, 2025)
  • K250927 — KARL STORZ Cholangiography Set (November 22, 2025)
  • K253411 — Miniature Telescope for Urology (27033AA) (November 18, 2025)
  • K250388 — ENDOFLATOR + (September 22, 2025)
  • K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)
  • K243550 — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (June 6, 2025)
  • K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fibersc (May 2, 2025)

Other clearances for product code FGA

  • K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (February 9, 2016)
  • K072594 — GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (December 13, 2007)
  • K994223 — NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 (June 5, 2000)
  • K950433 — KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES (March 15, 1995)
  • K940594 — KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE (September 9, 1994)
  • K922826 — FLEXIBLE FIBER OPTIC ENDOSCOPE (February 19, 1993)
  • K853486 — OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (September 12, 1985)
  • K791182 — ACMI RIGI-FLEX NEPHORSCOPE (July 30, 1979)
  • K770729 — PYELOSCOPE SYSTEM (April 28, 1977)