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FDA 510(k)

WOUND-EVAC

K-Number: K813341 · 1981-12-18

ApplicantHeritage Medical Products
Decision Date1981-12-18
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WOUND-EVAC is the device name listed in this FDA 510(k) record. The listed applicant is Heritage Medical Products. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813341. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOUND-EVAC?

WOUND-EVAC is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Heritage Medical Products. The 510(k) number is K813341.

When did WOUND-EVAC receive FDA 510(k) clearance?

WOUND-EVAC received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813341.

Who is the listed applicant for WOUND-EVAC?

The FDA 510(k) record lists Heritage Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOUND-EVAC?

The FDA product code for WOUND-EVAC is GCY.

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 Heritage Medical Products 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.

K881012WOUND-EVAC RS

Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, Inc.

Official Source

View on FDA Database →

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

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