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FDA 510(k)

URETHRAL CATHETERIZATION TRAYS

K-Number: K896212 · 1990-01-24

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1990-01-24
Product CodeFCM
Advisory CommitteeGU
DecisionUnknown

Device Summary

URETHRAL CATHETERIZATION TRAYS 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 1990-01-24 under 510(k) number K896212. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the URETHRAL CATHETERIZATION TRAYS?

URETHRAL CATHETERIZATION TRAYS is a medical device that received FDA 510(k) clearance on 1990-01-24. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896212.

When did URETHRAL CATHETERIZATION TRAYS receive FDA 510(k) clearance?

URETHRAL CATHETERIZATION TRAYS received FDA 510(k) clearance on 1990-01-24, under 510(k) number K896212.

Who is the listed applicant for URETHRAL CATHETERIZATION TRAYS?

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 URETHRAL CATHETERIZATION TRAYS?

The FDA product code for URETHRAL CATHETERIZATION TRAYS is FCM.

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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: FCM)

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.

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, 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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