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FDA 510(k)

RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET

K-Number: K963993 · 1996-12-17

ApplicantRusch, Inc.
Decision Date1996-12-17
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 1996-12-17 under 510(k) number K963993. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET?

RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET is a medical device that received FDA 510(k) clearance on 1996-12-17. The listed applicant is Rusch, Inc.. The 510(k) number is K963993.

When did RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET receive FDA 510(k) clearance?

RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET received FDA 510(k) clearance on 1996-12-17, under 510(k) number K963993.

Who is the listed applicant for RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET?

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 FOLEY CATHETERIZATION SET?

The FDA product code for RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET is FCM.

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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 CATHETERK974419RUSCH SIMPLASTIC COUNCILL TIP CATHETERK963779RUSCH ENTERAL FEEDING TUBE

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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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