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FDA 510(k)

BLOXOM IRRIGATOR

K-Number: K871791 · 1987-05-20

ApplicantI.B. Bloxom C/O Hogan & Hartson
Decision Date1987-05-20
Product CodeEXD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLOXOM IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is I.B. Bloxom C/O Hogan & Hartson. It received FDA 510(k) clearance on 1987-05-20 under 510(k) number K871791. 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 BLOXOM IRRIGATOR?

BLOXOM IRRIGATOR is a medical device that received FDA 510(k) clearance on 1987-05-20. The listed applicant is I.B. Bloxom C/O Hogan & Hartson. The 510(k) number is K871791.

When did BLOXOM IRRIGATOR receive FDA 510(k) clearance?

BLOXOM IRRIGATOR received FDA 510(k) clearance on 1987-05-20, under 510(k) number K871791.

Who is the listed applicant for BLOXOM IRRIGATOR?

The FDA 510(k) record lists I.B. Bloxom C/O Hogan & Hartson as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOXOM IRRIGATOR?

The FDA product code for BLOXOM IRRIGATOR is EXD.

Related Clinical Trials

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.

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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. SAK840268IRRIGATION SYSTEMColoplast A/SK832299VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & SonsK823274UNI-TIP COLOSTOMY IRRIGATION CONEHowmedica Corp.

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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