Home / 510(k) Clearances / K001270

510(k) K001270

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE by Gyrus Medical , Ltd. — Product Code FJL

K001270 is an FDA 510(k) premarket notification submitted by Gyrus Medical , Ltd. for the device "GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 28, 2000. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Gyrus Medical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2000
Date Received
April 20, 2000
Clearance Type
Special
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 Gyrus Medical , Ltd.

  • K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR (November 9, 2005)
  • K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES (October 25, 2005)
  • K041999 — GYRUS PLASMA SKIN RESURFACING SYSTEM (March 2, 2005)
  • K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA (October 22, 2004)
  • K041285 — GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION (September 10, 2004)
  • K024286 — GYRUS OPEN FORCEPS (November 17, 2003)
  • K031085 — GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) (July 21, 2003)
  • K031082 — EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK (May 21, 2003)
  • K031081 — EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS (May 21, 2003)
  • K031079 — EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE (May 21, 2003)

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)
  • K102663 — AED RESECTOSCOPE (December 30, 2010)
  • 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)

FDA data resources