FDA 510(k)

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

K-Number: K992218 · 1999-07-30

Decision Date1999-07-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 is the device name listed in this FDA 510(k) record. The listed applicant is Kirwan Surgical Products, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K992218. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601?

DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Kirwan Surgical Products, Inc.. The 510(k) number is K992218.

When did DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 receive FDA 510(k) clearance?

DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 received FDA 510(k) clearance on 1999-07-30, under 510(k) number K992218.

Who is the listed applicant for DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601?

The FDA 510(k) record lists Kirwan Surgical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601?

The FDA product code for DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 is GEI.

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Other records listing Kirwan Surgical Products, Inc. as applicant

K100912DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE K070360KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 K060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS K062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES K052203AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 K023482AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.