MultiGen™ 2 RF Generator System

Generator, Lesion, Radiofrequency

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Multigen™ 2 Rf Generator System.

Pre-market Notification Details

• Device ID: K170242
• 510k Number: K170242
• Device Name: MultiGen™ 2 RF Generator System
• Classification: Generator, Lesion, Radiofrequency
• Applicant: STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001
• Contact: Becky Ditty
• Correspondent: David Colao; STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001
• Product Code: GXD
• CFR Regulation Number: 882.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-26
• Decision Date: 2017-05-25
• Summary: summary