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FDA 510(k)

Saberscope5 Laparoscope

K-Number: K220872 · 2022-04-20

ApplicantXenocor, Inc.
Decision Date2022-04-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Saberscope5 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 2022-04-20 under 510(k) number K220872. 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 Saberscope5 Laparoscope?

Saberscope5 Laparoscope is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Xenocor, Inc.. The 510(k) number is K220872.

When did Saberscope5 Laparoscope receive FDA 510(k) clearance?

Saberscope5 Laparoscope received FDA 510(k) clearance on 2022-04-20, under 510(k) number K220872.

Who is the listed applicant for Saberscope5 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 Saberscope5 Laparoscope?

The FDA product code for Saberscope5 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)K193315Xenocor Articulating Xenoscope 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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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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