DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601

Electrosurgical, Cutting & Coagulation & Accessories

KIRWAN SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Disposable Irrigation Bipolar Cord Assembly For Malis System Cmc-ii, Model 10-4601.

Pre-market Notification Details

• Device ID: K992218
• 510k Number: K992218
• Device Name: DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• 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: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-07-01
• Decision Date: 1999-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841019122683	K992218	000