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510(k) K070877

ENDOCERVICAL ELECTRODE # 2 by Modern Medical Equipment Mfg., Ltd. — Product Code HGI

K070877 is an FDA 510(k) premarket notification submitted by Modern Medical Equipment Mfg., Ltd. for the device "ENDOCERVICAL ELECTRODE # 2". The FDA issued a decision of Substantially Equivalent on July 27, 2007. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Modern Medical Equipment Mfg., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2007
Date Received
March 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

Other clearances by Modern Medical Equipment Mfg., Ltd.

  • K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM (May 19, 2010)
  • K091511 — MODERN MEDICAL RESECTOSCOPE ELECTRODES (January 15, 2010)
  • K070812 — DISPOSABLE LAPAROSCOPIC INSTRUMENT (September 14, 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)
  • K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS (June 15, 2004)
  • K032327 — MODERN MEDICAL BIPOLAR FORCEPS (June 15, 2004)
  • K032965 — LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE (May 13, 2004)

Other clearances for product code HGI

  • K202915 — IRIS Thermocoagulator and Digital Colposcope (April 23, 2021)
  • K152843 — Liger Medical HTU-110 (June 24, 2016)
  • K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEM (January 3, 2014)
  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K022593 — THOMAS MEDICAL ELECTRODES (November 1, 2002)
  • K003608 — SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY (February 20, 2001)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)

FDA data resources