Cleared Traditional

LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head

K191177 · Smith and Nephew, Inc. · General & Plastic Surgery

Aug 2019

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K191177 is an FDA 510(k) clearance for the LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Smith and Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on August 23, 2019, 113 days after receiving the submission on May 2, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K191177 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2019
Decision Date	August 23, 2019
Days to Decision	113 days
Submission Type	Traditional
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).