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510(k) K091511

MODERN MEDICAL RESECTOSCOPE ELECTRODES by Modern Medical Equipment Mfg., Ltd. — Product Code FAS

K091511 is an FDA 510(k) premarket notification submitted by Modern Medical Equipment Mfg., Ltd. for the device "MODERN MEDICAL RESECTOSCOPE ELECTRODES". The FDA issued a decision of Substantially Equivalent on January 15, 2010. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Modern Medical Equipment Mfg., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2010
Date Received
May 22, 2009
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 Modern Medical Equipment Mfg., Ltd.

  • K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM (May 19, 2010)
  • K070812 — DISPOSABLE LAPAROSCOPIC INSTRUMENT (September 14, 2007)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K050842 — AGCEL WOUND DRESSING,AGCEL BURN DRESSING (August 2, 2006)
  • K043036 — NON-STICK ELECTRODE (May 6, 2005)
  • K033095 — SMOKE EVACUATION ATTACHEMENT (November 17, 2004)
  • K040238 — SOFTSEAL HSG CATHETER (June 22, 2004)
  • K032327 — MODERN MEDICAL BIPOLAR FORCEPS (June 15, 2004)
  • K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS (June 15, 2004)
  • K032965 — LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE (May 13, 2004)

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