ACCORDION

Dislodger, Stone, Basket, Ureteral, Metal

PERCUTANEOUS SYSTEMS, INCORPORATED

The following data is part of a premarket notification filed by Percutaneous Systems, Incorporated with the FDA for Accordion.

Pre-market Notification Details

• Device ID: K052048
• 510k Number: K052048
• Device Name: ACCORDION
• Classification: Dislodger, Stone, Basket, Ureteral, Metal
• Applicant: PERCUTANEOUS SYSTEMS, INCORPORATED 1300 CRITTENDEN LANE SUITE 301 Mountain View, CA 94043
• Contact: Thomas Lawson
• Correspondent: Thomas Lawson; PERCUTANEOUS SYSTEMS, INCORPORATED 1300 CRITTENDEN LANE SUITE 301 Mountain View, CA 94043
• Product Code: FFL
• CFR Regulation Number: 876.4680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-29
• Decision Date: 2005-09-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857252004023	K052048	000