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FDA 510(k)

Xenocor Articulating Xenoscope Laparoscope

K-Number: K193315 · 2020-01-27

ApplicantXenocor, Inc.
Decision Date2020-01-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Xenocor Articulating Xenoscope Laparoscope is the device name listed in this FDA 510(k) record. The listed applicant is Xenocor, Inc.. It received FDA 510(k) clearance on 2020-01-27 under 510(k) number K193315. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenocor Articulating Xenoscope Laparoscope?

Xenocor Articulating Xenoscope Laparoscope is a medical device that received FDA 510(k) clearance on 2020-01-27. The listed applicant is Xenocor, Inc.. The 510(k) number is K193315.

When did Xenocor Articulating Xenoscope Laparoscope receive FDA 510(k) clearance?

Xenocor Articulating Xenoscope Laparoscope received FDA 510(k) clearance on 2020-01-27, under 510(k) number K193315.

Who is the listed applicant for Xenocor Articulating Xenoscope Laparoscope?

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

What is the FDA product code for Xenocor Articulating Xenoscope Laparoscope?

The FDA product code for Xenocor Articulating Xenoscope Laparoscope is GCJ.

Other records listing Xenocor, 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.

K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)K220872Saberscope5 LaparoscopeK171344Xenocor Xenoscope Laparoscopic SystemK161838Xenocor Xenoscope Laparoscopic System

Related Devices (Code: GCJ)

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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