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FDA 510(k)

AKRO-SIL FOLEY KIT 30CC

K-Number: K771650 · 1977-09-20

ApplicantLatex Ind., Inc.
Decision Date1977-09-20
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AKRO-SIL FOLEY KIT 30CC is the device name listed in this FDA 510(k) record. The listed applicant is Latex Ind., Inc.. It received FDA 510(k) clearance on 1977-09-20 under 510(k) number K771650. 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 AKRO-SIL FOLEY KIT 30CC?

AKRO-SIL FOLEY KIT 30CC is a medical device that received FDA 510(k) clearance on 1977-09-20. The listed applicant is Latex Ind., Inc.. The 510(k) number is K771650.

When did AKRO-SIL FOLEY KIT 30CC receive FDA 510(k) clearance?

AKRO-SIL FOLEY KIT 30CC received FDA 510(k) clearance on 1977-09-20, under 510(k) number K771650.

Who is the listed applicant for AKRO-SIL FOLEY KIT 30CC?

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

What is the FDA product code for AKRO-SIL FOLEY KIT 30CC?

The FDA product code for AKRO-SIL FOLEY KIT 30CC is FCM.

Related Clinical Trials

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Other records listing Latex Ind., 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.

K812058AKRON URINARY DRAINAGE BATK810281UROLOGICAL CATHETERSK791674BLADDER RETENTION CATHETERIZATION TRAYK781751CATHETER, AKRON FOLEY TEFLONK781433AKRON MALE EXTERNAL CATHETERK772277BLADDER RETENTION-CATHETHERIZATIONTRAY

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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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