Cleared Traditional

GLOVE PORT

K141715 · Nelis · General & Plastic Surgery

Mar 2015

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K141715 is an FDA 510(k) clearance for the GLOVE PORT, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Nelis (Pittsburgh, US). The FDA issued a Cleared decision on March 25, 2015, 273 days after receiving the submission on June 25, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K141715 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2014
Decision Date	March 25, 2015
Days to Decision	273 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).