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510(k) K244001

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) by Karl Storz SE & CO. KG — Product Code FBO

K244001 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Karl Storz SE & CO. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
December 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystourethroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Karl Storz SE & CO. KG

  • K261706 — Endomat Select (UP220) (July 16, 2026)
  • K252800 — KARL STORZ Endoscopic Accessories for Urology (June 3, 2026)
  • K254228 — KARL STORZ Trocars with Valve Seals (May 11, 2026)
  • 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)

Other clearances for product code FBO

  • K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (November 27, 2024)
  • K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (January 2, 2014)
  • K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND C (October 10, 2008)
  • K080780 — ANCHORAGE SCOPE, MODEL 000003 (July 30, 2008)
  • K062918 — KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM (January 17, 2007)
  • K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (June 27, 2006)
  • K011496 — CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENT (August 10, 2001)
  • K972979 — SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RI (December 11, 1997)
  • K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (December 20, 1996)
  • K941992 — CYSTOSCOPE (November 30, 1995)

FDA data resources