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510(k) K151308

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set by Schoelly Fiberoptic GmbH — Product Code FGA

K151308 is an FDA 510(k) premarket notification submitted by Schoelly Fiberoptic GmbH for the device "Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set". The FDA issued a decision of Substantially Equivalent on February 9, 2016. The device falls under product code FGA (Kit, Nephroscope), a Class II device regulated under 21 CFR 876.1500. Schoelly Fiberoptic GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2016
Date Received
May 18, 2015
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 Schoelly Fiberoptic GmbH

  • K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Cam (June 20, 2024)
  • K221591 — Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic sc (February 23, 2023)
  • K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera (March 12, 2021)
  • K201970 — Schoelly Cystoscopes/Hysteroscopes and Accessories (October 8, 2020)
  • K150158 — Schoelly Cystoscopes/Hysteroscopes and Accessories (March 9, 2015)
  • K143673 — CMOS Video Nasopharyngoscope System (March 4, 2015)
  • K142249 — SCHOELLY SINUSCOPE (January 27, 2015)
  • K143221 — Schoelly Laparoscope (December 5, 2014)
  • K132009 — CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM (April 9, 2014)
  • K992362 — FLEXISCOPE IQ 101 (August 5, 1999)

Other clearances for product code FGA

  • K232370 — Percutaneous Nephroscope System (May 1, 2024)
  • 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)

FDA data resources