USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE

Electrode, Electrosurgical, Active, Urological

CIRCON CORP.

The following data is part of a premarket notification filed by Circon Corp. with the FDA for Usa Elite System Vaportrode Vaporization Electrode And Vaportome Resection Electrode.

Pre-market Notification Details

• Device ID: K973820
• 510k Number: K973820
• Device Name: USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
• Classification: Electrode, Electrosurgical, Active, Urological
• Applicant: CIRCON CORP. 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019
• Contact: Andrew D Simons
• Correspondent: Andrew D Simons; CIRCON CORP. 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019
• Product Code: FAS
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-10-07
• Decision Date: 1998-05-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821925008120	K973820	000
00821925008106	K973820	000
00821925008090	K973820	000
00821925038851	K973820	000
00821925008113	K973820	000