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510(k) K993527

LOOP ELECTRODE, BALL ELECTRODE by Palm Medical USA, Inc. — Product Code HGI

K993527 is an FDA 510(k) premarket notification submitted by Palm Medical USA, Inc. for the device "LOOP ELECTRODE, BALL ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 6, 2000. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2000
Date Received
October 18, 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

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  • 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)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)

FDA data resources