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FDA 510(k)

ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

K-Number: K061829 · 2006-11-17

ApplicantNew Leaf Medical, Inc.
Decision Date2006-11-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is New Leaf Medical, Inc.. It received FDA 510(k) clearance on 2006-11-17 under 510(k) number K061829. 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 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES?

ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2006-11-17. The listed applicant is New Leaf Medical, Inc.. The 510(k) number is K061829.

When did ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES receive FDA 510(k) clearance?

ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES received FDA 510(k) clearance on 2006-11-17, under 510(k) number K061829.

Who is the listed applicant for ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES?

The FDA 510(k) record lists New Leaf Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES?

The FDA product code for ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES is GEI.

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Other records listing New Leaf Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073455E-VAC

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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.

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