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FDA 510(k)

QUARTZ RODS TITANIUM RODS

K-Number: K862472 · 1986-09-12

ApplicantQuali-Med, Inc.
Decision Date1986-09-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUARTZ RODS TITANIUM RODS is the device name listed in this FDA 510(k) record. The listed applicant is Quali-Med, Inc.. It received FDA 510(k) clearance on 1986-09-12 under 510(k) number K862472. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUARTZ RODS TITANIUM RODS?

QUARTZ RODS TITANIUM RODS is a medical device that received FDA 510(k) clearance on 1986-09-12. The listed applicant is Quali-Med, Inc.. The 510(k) number is K862472.

When did QUARTZ RODS TITANIUM RODS receive FDA 510(k) clearance?

QUARTZ RODS TITANIUM RODS received FDA 510(k) clearance on 1986-09-12, under 510(k) number K862472.

Who is the listed applicant for QUARTZ RODS TITANIUM RODS?

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

What is the FDA product code for QUARTZ RODS TITANIUM RODS?

The FDA product code for QUARTZ RODS TITANIUM RODS is GEX. This falls under the Gastroenterology category.

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Other records listing Quali-Med, 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.

K871408BLOOD VESSEL CONNECTORK862972DISPOSABLE MIRRORK862241STANDARD BASIN KIT CUSTOM BASIN KITK862242PAP SMEAR KITK862172QUALI-MED'S OPERATING ROOM DRAPESK861198CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)

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Related Devices (Code: GEX)

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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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