FDA 510(k)

Saberscope5 Laparoscope

K-Number: K220872 · 2022-04-20

Decision Date2022-04-20

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Saberscope5 Laparoscope is a medical device manufactured by Xenocor, Inc.. It received FDA 510(k) clearance on 2022-04-20 under approval 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. It is manufactured by Xenocor, Inc.. The 510(k) number is K220872.

When was Saberscope5 Laparoscope approved by the FDA?

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

What company makes Saberscope5 Laparoscope?

Saberscope5 Laparoscope is manufactured by Xenocor, Inc..

What is the FDA product code for Saberscope5 Laparoscope?

The FDA product code for Saberscope5 Laparoscope is GCJ.

Other Devices by Xenocor, Inc.

K161838Xenocor Xenoscope Laparoscopic System K171344Xenocor Xenoscope Laparoscopic System K193315Xenocor Articulating Xenoscope Laparoscope K260177Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

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.