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510(k) K102663

AED RESECTOSCOPE by National Advanced Endoscopy Devices, Inc. — Product Code FJL

K102663 is an FDA 510(k) premarket notification submitted by National Advanced Endoscopy Devices, Inc. for the device "AED RESECTOSCOPE". The FDA issued a decision of Substantially Equivalent on December 30, 2010. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. National Advanced Endoscopy Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2010
Date Received
September 15, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by National Advanced Endoscopy Devices, Inc.

  • K170285 — AED Sinuscope (August 1, 2017)
  • K141515 — AED HYSTEROSCOPE AND ACCESSORIES (January 7, 2015)
  • K081553 — AED BIPOLAR FORCEPS, MODEL 13-1646 (September 29, 2008)
  • K081503 — AED MONOPOLAR LAP ACCESSORIES (September 25, 2008)
  • K993689 — AED CYSTOSCOPE (December 15, 1999)
  • K993688 — AED LAPAROSCOPE (December 6, 1999)
  • K991656 — AED ARTHROSCOPE (December 2, 1999)

Other clearances for product code FJL

  • K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable (May 7, 2024)
  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
  • K230205 — Veloxion System (February 24, 2023)
  • K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo (June 13, 2019)
  • K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Velo (March 15, 2019)
  • K162979 — Veloxion System (March 24, 2017)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K042523 — RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSOR (March 18, 2005)
  • K041610 — MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (August 19, 2004)
  • K001270 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE (April 28, 2000)

FDA data resources