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510(k) K130606

FMWAND FERROMAGNETIC SURGICAL SYSTEM by Domain Surgical, Inc. — Product Code HGI

K130606 is an FDA 510(k) premarket notification submitted by Domain Surgical, Inc. for the device "FMWAND FERROMAGNETIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 2014. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Domain Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2014
Date Received
March 7, 2013
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 Domain Surgical, Inc.

  • K142229 — Laparoscopic FMsealer (January 2, 2015)
  • K141484 — OPEN FMSEALER (July 30, 2014)
  • K140384 — FMWAND HANDPIECE SE (May 23, 2014)
  • K121881 — DOMAIN SURGICAL SYSTEM (October 18, 2012)
  • K110439 — DOMAIN SURGICAL SYSTEM (July 18, 2011)

Other clearances for product code HGI

  • K202915 — IRIS Thermocoagulator and Digital Colposcope (April 23, 2021)
  • K152843 — Liger Medical HTU-110 (June 24, 2016)
  • 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)
  • 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