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FDA 510(k)

SOLUTIS

K-Number: K130933 · 2013-08-02

ApplicantQuantel Medical
Decision Date2013-08-02
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOLUTIS is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2013-08-02 under 510(k) number K130933. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLUTIS?

SOLUTIS is a medical device that received FDA 510(k) clearance on 2013-08-02. The listed applicant is Quantel Medical. The 510(k) number is K130933.

When did SOLUTIS receive FDA 510(k) clearance?

SOLUTIS received FDA 510(k) clearance on 2013-08-02, under 510(k) number K130933.

Who is the listed applicant for SOLUTIS?

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

What is the FDA product code for SOLUTIS?

The FDA product code for SOLUTIS is HQF.

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Other records listing Quantel Medical 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: HQF)

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

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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