Cleared Traditional

K111002 - REPROCESSED ENDOSCOPIC TROCARS
(FDA 510(k) Clearance)

K111002 · Sterilmed, Inc. · Gastroenterology & Urology

Jul 2011

Decision

98d

Days

Class 2

Risk

K111002 is an FDA 510(k) clearance for the REPROCESSED ENDOSCOPIC TROCARS. This device is classified as a Laparoscope, General & Plastic Surgery, Reprocessed (Class II — Special Controls, product code NLM).

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 18, 2011, 98 days after receiving the submission on April 11, 2011.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..

Submission Details

510(k) Number	K111002 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2011
Decision Date	July 18, 2011
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	NLM — Laparoscope, General & Plastic Surgery, Reprocessed
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).