Cleared Special

Xenocor Xenoscope Laparoscopic System

K171344 · Xenocor, Inc. · General & Plastic Surgery

Jun 2017

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K171344 is an FDA 510(k) clearance for the Xenocor Xenoscope Laparoscopic System, 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 June 1, 2017, 24 days after receiving the submission on May 8, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K171344 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2017
Decision Date	June 01, 2017
Days to Decision	24 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).