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FDA 510(k)

ACL TOP Family 70 Series

K-Number: K231031 · 2023-06-21

Decision Date2023-06-21
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACL TOP Family 70 Series is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory Company. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K231031. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACL TOP Family 70 Series?

ACL TOP Family 70 Series is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Instrumentation Laboratory Company. The 510(k) number is K231031.

When did ACL TOP Family 70 Series receive FDA 510(k) clearance?

ACL TOP Family 70 Series received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231031.

Who is the listed applicant for ACL TOP Family 70 Series?

The FDA 510(k) record lists Instrumentation Laboratory Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACL TOP Family 70 Series?

The FDA product code for ACL TOP Family 70 Series is GKP.

Other records listing Instrumentation Laboratory Company 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.

View all 29 devices →

Related Devices (Code: GKP)

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.

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.