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FDA 510(k)

MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM

K-Number: K072684 · 2008-01-04

ApplicantMondeal North America, Inc.
Decision Date2008-01-04
Product CodeOCZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mondeal North America, Inc.. It received FDA 510(k) clearance on 2008-01-04 under 510(k) number K072684. The device is classified under product code OCZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM?

MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-04. The listed applicant is Mondeal North America, Inc.. The 510(k) number is K072684.

When did MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM receive FDA 510(k) clearance?

MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM received FDA 510(k) clearance on 2008-01-04, under 510(k) number K072684.

Who is the listed applicant for MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM?

The FDA 510(k) record lists Mondeal North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM?

The FDA product code for MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM is OCZ.

Related Clinical Trials

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Related Devices (Code: OCZ)

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.

K252800KARL STORZ Endoscopic Accessories for UrologyKarl Storz SE & CO. KGK242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)Envision EndoscopyK191900Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd.K152802Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd.K120084ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.K103688G-PROX EZ ENDOSCOPIC GRASPERUsgi Medical

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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