Cleared Traditional

REPROCESSED ENDOSCOPIC TROCARS

K121240 · Sterilmed, Inc. · Gastroenterology & Urology

Jun 2012

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K121240 is an FDA 510(k) clearance for the REPROCESSED ENDOSCOPIC TROCARS, 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 June 11, 2012, 48 days after receiving the submission on April 24, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K121240 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2012
Decision Date	June 11, 2012
Days to Decision	48 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).