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FDA 510(k)

Glide (91000-GL-X)

K-Number: K240884 · 2024-04-15

ApplicantInfinite Biomedical Technologies, LLC
Decision Date2024-04-15
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Glide (91000-GL-X) is the device name listed in this FDA 510(k) record. The listed applicant is Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2024-04-15 under 510(k) number K240884. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Glide (91000-GL-X)?

Glide (91000-GL-X) is a medical device that received FDA 510(k) clearance on 2024-04-15. The listed applicant is Infinite Biomedical Technologies, LLC. The 510(k) number is K240884.

When did Glide (91000-GL-X) receive FDA 510(k) clearance?

Glide (91000-GL-X) received FDA 510(k) clearance on 2024-04-15, under 510(k) number K240884.

Who is the listed applicant for Glide (91000-GL-X)?

The FDA 510(k) record lists Infinite Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glide (91000-GL-X)?

The FDA product code for Glide (91000-GL-X) is GXY.

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.

NCT06539936Regulatory Clearance of the Glide Control Strategy for Upper Limb ProsthesesRECRUITING

Other records listing Infinite Biomedical Technologies, LLC 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.

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Related Devices (Code: GXY)

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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