ASCEND

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

CALDERA MEDICAL, INC.

The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Ascend.

Pre-market Notification Details

• Device ID: K083722
• 510k Number: K083722
• Device Name: ASCEND
• Classification: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
• Applicant: CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301
• Contact: Mara Korsunsky
• Correspondent: Mara Korsunsky; CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301
• Product Code: OTP
• CFR Regulation Number: 884.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-15
• Decision Date: 2009-03-31
• Summary: summary