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FDA 510(k)

VISECERA RETAINER

K-Number: K802806 · 1981-01-23

ApplicantAdept-Med Intl., Inc.
Decision Date1981-01-23
Product CodeGCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISECERA RETAINER is the device name listed in this FDA 510(k) record. The listed applicant is Adept-Med Intl., Inc.. It received FDA 510(k) clearance on 1981-01-23 under 510(k) number K802806. The device is classified under product code GCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISECERA RETAINER?

VISECERA RETAINER is a medical device that received FDA 510(k) clearance on 1981-01-23. The listed applicant is Adept-Med Intl., Inc.. The 510(k) number is K802806.

When did VISECERA RETAINER receive FDA 510(k) clearance?

VISECERA RETAINER received FDA 510(k) clearance on 1981-01-23, under 510(k) number K802806.

Who is the listed applicant for VISECERA RETAINER?

The FDA 510(k) record lists Adept-Med Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISECERA RETAINER?

The FDA product code for VISECERA RETAINER is GCZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Adept-Med Intl., 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.

K935636GRAVESPECK893871GOOTT BALFOUR BLADEK893869GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)K893870ADAMS BREAST IMPLANT PROTECTORK870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206

Related Devices (Code: GCZ)

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.

K904536JAIN GRAFT ASSISTJain Surgical Equipment, Inc.K893870ADAMS BREAST IMPLANT PROTECTORAdept-Med Intl., Inc.K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc.K801610CHILDREN'S HOSPITAL PEDIATRIC RETRACTOREdward Weck, Inc.

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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