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FDA 510(k)

UMBILI-CATH-S

K-Number: K940953 · 1994-08-02

ApplicantGesco Intl., Inc.
Decision Date1994-08-02
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UMBILI-CATH-S is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K940953. The device is classified under product code FOS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UMBILI-CATH-S?

UMBILI-CATH-S is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K940953.

When did UMBILI-CATH-S receive FDA 510(k) clearance?

UMBILI-CATH-S received FDA 510(k) clearance on 1994-08-02, under 510(k) number K940953.

Who is the listed applicant for UMBILI-CATH-S?

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

What is the FDA product code for UMBILI-CATH-S?

The FDA product code for UMBILI-CATH-S is FOS.

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Other records listing Gesco Intl., 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.

K954422PER-Q-CATH MID-LINEK940870UMBILI-CATHK940952UMBILI-CATH-S-DLK941672URI-CATH CATHETERK941232THORA-CATHK940871UMBILI-CATH-P

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Related Devices (Code: FOS)

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.

K201697Umbilical Vessels CatheterHaolang Medical USA CorporationK130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.Covidien Lp, Formerly Registered AS KendallK120304FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETERFootprint Medical, Inc.K091213FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENFootprint MedicalK091214FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETERFootprint MedicalK081515NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0Neomed, 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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