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FDA 510(k)

TUBE, GASTRO-ENTEROSTOMY

K-Number: K760810 · 1977-02-28

ApplicantSherwood Medical Industries
Decision Date1977-02-28
Product CodeEXD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TUBE, GASTRO-ENTEROSTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Industries. It received FDA 510(k) clearance on 1977-02-28 under 510(k) number K760810. The device is classified under product code EXD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBE, GASTRO-ENTEROSTOMY?

TUBE, GASTRO-ENTEROSTOMY is a medical device that received FDA 510(k) clearance on 1977-02-28. The listed applicant is Sherwood Medical Industries. The 510(k) number is K760810.

When did TUBE, GASTRO-ENTEROSTOMY receive FDA 510(k) clearance?

TUBE, GASTRO-ENTEROSTOMY received FDA 510(k) clearance on 1977-02-28, under 510(k) number K760810.

Who is the listed applicant for TUBE, GASTRO-ENTEROSTOMY?

The FDA 510(k) record lists Sherwood Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUBE, GASTRO-ENTEROSTOMY?

The FDA product code for TUBE, GASTRO-ENTEROSTOMY is EXD.

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Other records listing Sherwood Medical Industries 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.

K801070SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLESK801071LANCER GLUCOSE RATE REAGENT KITK792014LANCER L-INA BUFFER, POLYMER, WASH SOLUK792013LANCER L-INA HUMAN REFERENCE SERUMK782077LANCER ICE CUBEK790523ARGYLE ESOPHAGEAL STETHOSCOPE

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Related Devices (Code: EXD)

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.

K121833OSTOMY IRRIGATION SETColoplast A/SK914692URINARY DIVERSION EVACUATING CATHETERCook Urological, Inc.K904586PALEX IRRIGATION SETPalex Intl. SAK871791BLOXOM IRRIGATORI.B. Bloxom C/O Hogan & HartsonK840268IRRIGATION SYSTEMColoplast A/SK832299VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & Sons

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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