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FDA 510(k)

CLOSED WOUND DRAIN

K-Number: K850037 · 1985-03-19

ApplicantConsolidated Medical Equipment, Inc.
Decision Date1985-03-19
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLOSED WOUND DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Medical Equipment, Inc.. It received FDA 510(k) clearance on 1985-03-19 under 510(k) number K850037. 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 CLOSED WOUND DRAIN?

CLOSED WOUND DRAIN is a medical device that received FDA 510(k) clearance on 1985-03-19. The listed applicant is Consolidated Medical Equipment, Inc.. The 510(k) number is K850037.

When did CLOSED WOUND DRAIN receive FDA 510(k) clearance?

CLOSED WOUND DRAIN received FDA 510(k) clearance on 1985-03-19, under 510(k) number K850037.

Who is the listed applicant for CLOSED WOUND DRAIN?

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

What is the FDA product code for CLOSED WOUND DRAIN?

The FDA product code for CLOSED WOUND DRAIN is GCY.

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Other records listing Consolidated Medical Equipment, 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.

K854040I.V. DRESSINGK850130PRN ECG ELECTRODEK850132DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELECK844942PLURA-GARD CHEST DRAINAGE SYSTEMK850311DISPOS. CONDUCTIVE ADHESIVE TENS PADK850131CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS

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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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