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510(k) K002042

TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 by New England Medical Corp. — Product Code HGI

K002042 is an FDA 510(k) premarket notification submitted by New England Medical Corp. for the device "TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018". The FDA issued a decision of Substantially Equivalent on February 1, 2001. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. New England Medical Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2001
Date Received
July 5, 2000
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 New England Medical Corp.

  • K931982 — NEW ENGLAND MEDICAL GROUNDING PAD (October 5, 1993)

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)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • 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)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)

FDA data resources