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FDA 510(k)

PORTABLE CLOSED WOUND SUCTION EVACUATOR

K-Number: K780848 · 1978-08-23

ApplicantBiomet, Inc.
Decision Date1978-08-23
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PORTABLE CLOSED WOUND SUCTION EVACUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1978-08-23 under 510(k) number K780848. 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 PORTABLE CLOSED WOUND SUCTION EVACUATOR?

PORTABLE CLOSED WOUND SUCTION EVACUATOR is a medical device that received FDA 510(k) clearance on 1978-08-23. The listed applicant is Biomet, Inc.. The 510(k) number is K780848.

When did PORTABLE CLOSED WOUND SUCTION EVACUATOR receive FDA 510(k) clearance?

PORTABLE CLOSED WOUND SUCTION EVACUATOR received FDA 510(k) clearance on 1978-08-23, under 510(k) number K780848.

Who is the listed applicant for PORTABLE CLOSED WOUND SUCTION EVACUATOR?

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

What is the FDA product code for PORTABLE CLOSED WOUND SUCTION EVACUATOR?

The FDA product code for PORTABLE CLOSED WOUND SUCTION EVACUATOR is GCY.

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Other records listing Biomet, Inc. as applicant

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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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