Cleared Traditional

GELPORT BLUNT TIP TROCAR SYSTEM

K060629 · Applied Medical Resources Corp. · General & Plastic Surgery

Apr 2006

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K060629 is an FDA 510(k) clearance for the GELPORT BLUNT TIP TROCAR SYSTEM, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on April 7, 2006, 29 days after receiving the submission on March 9, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K060629 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2006
Decision Date	April 07, 2006
Days to Decision	29 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).