Cleared Special

Saberscope5 Laparoscope

K220872 · Xenocor, Inc. · General & Plastic Surgery

Apr 2022

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K220872 is an FDA 510(k) clearance for the Saberscope5 Laparoscope, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Xenocor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 20, 2022, 26 days after receiving the submission on March 25, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K220872 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2022
Decision Date	April 20, 2022
Days to Decision	26 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).