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510(k) K993777

DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES by R-Group Intl. — Product Code HGI

K993777 is an FDA 510(k) premarket notification submitted by R-Group Intl. for the device "DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES". The FDA issued a decision of Substantially Equivalent on May 25, 2000. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. R-Group Intl. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2000
Date Received
November 8, 1999
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 R-Group Intl.

  • K001233 — ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S (December 13, 2000)
  • K001599 — ACTI-FLEX IV ADMINISTRATION SET (September 18, 2000)
  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K940319 — R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE (November 10, 1994)
  • K913267 — R-GROUP INTL. ONE WALL PUNCTURE NEEDLE (June 5, 1992)

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)
  • K002042 — TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (February 1, 2001)
  • K993527 — LOOP ELECTRODE, BALL ELECTRODE (July 6, 2000)

FDA data resources