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FDA 510(k)

RUSCH SIMPLASTIC COUNCILL TIP CATHETER

K-Number: K974419 · 1998-01-27

ApplicantRusch, Inc.
Decision Date1998-01-27
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RUSCH SIMPLASTIC COUNCILL TIP CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 1998-01-27 under 510(k) number K974419. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH SIMPLASTIC COUNCILL TIP CATHETER?

RUSCH SIMPLASTIC COUNCILL TIP CATHETER is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Rusch, Inc.. The 510(k) number is K974419.

When did RUSCH SIMPLASTIC COUNCILL TIP CATHETER receive FDA 510(k) clearance?

RUSCH SIMPLASTIC COUNCILL TIP CATHETER received FDA 510(k) clearance on 1998-01-27, under 510(k) number K974419.

Who is the listed applicant for RUSCH SIMPLASTIC COUNCILL TIP CATHETER?

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

What is the FDA product code for RUSCH SIMPLASTIC COUNCILL TIP CATHETER?

The FDA product code for RUSCH SIMPLASTIC COUNCILL TIP CATHETER is EZL.

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Other records listing Rusch, 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.

K010420RUSCH MMG/O'NEIL CATHETERK993528RUSCH EMERGENCY MASKK993194RUSCH MANUAL RESUSCITATOR BAGK980870RUSCH SILICONE FOLEY CATHETERK963779RUSCH ENTERAL FEEDING TUBEK970021RUSCH SUPRAPUBIC TRAY

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Related Devices (Code: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, 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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