Reprocessed HARMONIC ACE+ 7 Shears With Advanced Hemostasis

Instrument, Ultrasonic Surgical

Sterilmed, Inc.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Ace+ 7 Shears With Advanced Hemostasis.

Pre-market Notification Details

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• Device ID: K182272
• 510k Number: K182272
• Device Name: Reprocessed HARMONIC ACE+ 7 Shears With Advanced Hemostasis
• Classification: Instrument, Ultrasonic Surgical
• Applicant: Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446
• Contact: Jan Flegeau
• Correspondent: Jan Flegeau; Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446
• Product Code: LFL
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-22
• Decision Date: 2019-04-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888551045278	K182272	000
10888551045247	K182272	000
10888551045230	K182272	000