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FDA 510(k)

CLOSED WOUND SUCTION DEVICE

K-Number: K883472 · 1988-10-18

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1988-10-18
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLOSED WOUND SUCTION DEVICE 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 1988-10-18 under 510(k) number K883472. 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 SUCTION DEVICE?

CLOSED WOUND SUCTION DEVICE is a medical device that received FDA 510(k) clearance on 1988-10-18. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K883472.

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

CLOSED WOUND SUCTION DEVICE received FDA 510(k) clearance on 1988-10-18, under 510(k) number K883472.

Who is the listed applicant for CLOSED WOUND SUCTION DEVICE?

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 SUCTION DEVICE?

The FDA product code for CLOSED WOUND SUCTION DEVICE 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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