DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE

Electrode, Needle

KIRWAN SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator Probe, Bipolar Side By Side.

Pre-market Notification Details

• Device ID: K100912
• 510k Number: K100912
• Device Name: DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
• Classification: Electrode, Needle
• Applicant: KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050
• Contact: Kevin P Prario
• Correspondent: Kevin P Prario; KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050
• Product Code: GXZ
• CFR Regulation Number: 882.1350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-04-01
• Decision Date: 2010-08-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20841019110229	K100912	000
20841019110212	K100912	000
20841019110205	K100912	000
20841019108196	K100912	000
20841019108189	K100912	000
20841019108172	K100912	000
20841019108165	K100912	000