XTOOL

Arthroscope

OUROBOROS MEDICAL

The following data is part of a premarket notification filed by Ouroboros Medical with the FDA for Xtool.

Pre-market Notification Details

• Device ID: K122861
• 510k Number: K122861
• Device Name: XTOOL
• Classification: Arthroscope
• Applicant: OUROBOROS MEDICAL 47757 FREMONT BLVD Fremont, CA 94538
• Contact: Shelley Trimm
• Correspondent: Shelley Trimm; OUROBOROS MEDICAL 47757 FREMONT BLVD Fremont, CA 94538
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-18
• Decision Date: 2012-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705034507439	K122861	000
10705034507422	K122861	000
10705034507415	K122861	000
10705034507408	K122861	000
10705034507392	K122861	000
10705034507385	K122861	000
10705034507378	K122861	000
10705034507361	K122861	000