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FDA 510(k)

CYSTOSCOPY/IRRIGATION SET

K-Number: K896211 · 1990-01-18

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1990-01-18
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYSTOSCOPY/IRRIGATION SET 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 1990-01-18 under 510(k) number K896211. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYSTOSCOPY/IRRIGATION SET?

CYSTOSCOPY/IRRIGATION SET is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896211.

When did CYSTOSCOPY/IRRIGATION SET receive FDA 510(k) clearance?

CYSTOSCOPY/IRRIGATION SET received FDA 510(k) clearance on 1990-01-18, under 510(k) number K896211.

Who is the listed applicant for CYSTOSCOPY/IRRIGATION SET?

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 CYSTOSCOPY/IRRIGATION SET?

The FDA product code for CYSTOSCOPY/IRRIGATION SET is KOD.

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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: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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