FDA 510(k)

X-FLO

K-Number: K800110 · 1980-02-06

ApplicantContemporary Surgical Systems, Inc.

Decision Date1980-02-06

Product CodeHQE

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

X-FLO is the device name listed in this FDA 510(k) record. The listed applicant is Contemporary Surgical Systems, Inc.. It received FDA 510(k) clearance on 1980-02-06 under 510(k) number K800110. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-FLO?

X-FLO is a medical device that received FDA 510(k) clearance on 1980-02-06. The listed applicant is Contemporary Surgical Systems, Inc.. The 510(k) number is K800110.

When did X-FLO receive FDA 510(k) clearance?

X-FLO received FDA 510(k) clearance on 1980-02-06, under 510(k) number K800110.

Who is the listed applicant for X-FLO?

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

What is the FDA product code for X-FLO?

The FDA product code for X-FLO is HQE.

Other records listing Contemporary Surgical Systems, Inc. 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.

K830040DISPOSABLE CYSTOTOME K791917X-PAK

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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.