Cleared Special

360 GAS ASSISTED ENDOSCOPIC APPLICATOR

K122526 · Micromedics, Inc. · General & Plastic Surgery

Nov 2012

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K122526 is an FDA 510(k) clearance for the 360 GAS ASSISTED ENDOSCOPIC APPLICATOR, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 16, 2012, 88 days after receiving the submission on August 20, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K122526 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2012
Decision Date	November 16, 2012
Days to Decision	88 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).