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FDA 510(k)

CryoGlow (FW3XXXX)

K-Number: K242796 · 2024-11-27

ApplicantSharkninja Operating, LLC
Decision Date2024-11-27
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoGlow (FW3XXXX) is the device name listed in this FDA 510(k) record. The listed applicant is Sharkninja Operating, LLC. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K242796. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryoGlow (FW3XXXX)?

CryoGlow (FW3XXXX) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Sharkninja Operating, LLC. The 510(k) number is K242796.

When did CryoGlow (FW3XXXX) receive FDA 510(k) clearance?

CryoGlow (FW3XXXX) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K242796.

Who is the listed applicant for CryoGlow (FW3XXXX)?

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

What is the FDA product code for CryoGlow (FW3XXXX)?

The FDA product code for CryoGlow (FW3XXXX) is OHS.

Related Devices (Code: OHS)

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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