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FDA 510(k)

CLOSED WOUND RESERVOIR

K-Number: K896803 · 1989-12-27

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1989-12-27
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLOSED WOUND RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K896803. 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 RESERVOIR?

CLOSED WOUND RESERVOIR is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896803.

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

CLOSED WOUND RESERVOIR received FDA 510(k) clearance on 1989-12-27, under 510(k) number K896803.

Who is the listed applicant for CLOSED WOUND RESERVOIR?

The FDA 510(k) record lists Westmark, Sterile Packing Systems, Inc. (Sps) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLOSED WOUND RESERVOIR?

The FDA product code for CLOSED WOUND RESERVOIR is GCY.

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Other records listing Westmark, Sterile Packing Systems, Inc. (Sps) 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.

K896800IRRIGATION TRAYK896799PARACERVICAL/PUDENDAL TRAYSK896559INFANT FEEDING TUBEK896794SPECIMEN CONTAINERK896806CATHETER PLUG/PROTECTORK896798TRACHEOSTOMY TRAY

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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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