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FDA 510(k)

ACL-5500

K-Number: K930210 · 1993-04-23

ApplicantIlt Systems, Inc.
Decision Date1993-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACL-5500 is the device name listed in this FDA 510(k) record. The listed applicant is Ilt Systems, Inc.. It received FDA 510(k) clearance on 1993-04-23 under 510(k) number K930210. 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 ACL-5500?

ACL-5500 is a medical device that received FDA 510(k) clearance on 1993-04-23. The listed applicant is Ilt Systems, Inc.. The 510(k) number is K930210.

When did ACL-5500 receive FDA 510(k) clearance?

ACL-5500 received FDA 510(k) clearance on 1993-04-23, under 510(k) number K930210.

Who is the listed applicant for ACL-5500?

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

What is the FDA product code for ACL-5500?

The FDA product code for ACL-5500 is GEX. This falls under the Gastroenterology category.

Related Devices (Code: GEX)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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