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510(k) K933174

GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE by Greenwald Surgical Co., Inc. — Product Code FAS

K933174 is an FDA 510(k) premarket notification submitted by Greenwald Surgical Co., Inc. for the device "GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 1, 1994. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Greenwald Surgical Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1994
Date Received
June 29, 1993
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 Greenwald Surgical Co., Inc.

  • K933173 — GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE (April 1, 1994)
  • K933175 — GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE (April 1, 1994)
  • K780137 — CLAMP, INCONTINENCE, BAUMRUCKER (April 28, 1978)

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