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510(k) K961702

KSEA VAPORIZATION ELECTRODES by Karl Storz Endoskop GmbH — Product Code FAS

K961702 is an FDA 510(k) premarket notification submitted by Karl Storz Endoskop GmbH for the device "KSEA VAPORIZATION ELECTRODES". The FDA issued a decision of Substantially Equivalent on August 29, 1996. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Karl Storz Endoskop GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
May 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Karl Storz Endoskop GmbH

  • K973068 — KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING (November 7, 1997)
  • K953368 — LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES (September 18, 1995)
  • K943713 — TORCARS,CANNULAE,SHEATHS,OBTURATORS (June 30, 1995)
  • K951995 — KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR (May 24, 1995)
  • K943053 — KSEA SEMM TISSUR PUNCH (March 21, 1995)
  • K943435 — CHOLANGIOGRAPHY SET (November 7, 1994)
  • K944823 — KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES (November 2, 1994)
  • K943904 — RIGID TELESCOPES (October 14, 1994)
  • K943697 — TROCARS,CANNULAE,SHEATHS,OBTURATORS (September 14, 1994)
  • K943816 — TROCARS,CANNULAE, SHEATHS (August 24, 1994)

Other clearances for product code FAS

  • K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Elect (December 5, 2025)
  • K250522 — Multi4 System (June 27, 2025)
  • K240504 — PLASMA EDGE System (June 12, 2024)
  • K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, (March 2, 2022)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K171965 — Resection Electrodes with HF cable (September 28, 2017)
  • K163090 — Plasma Edge System (May 23, 2017)
  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K152092 — Resection Electrodes (October 26, 2015)

FDA data resources