Cleared Traditional

DeRoyal Laprador Specimen Retrieval System

K171475 · Deroyal Industries, Inc. · General & Plastic Surgery

Aug 2017

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K171475 is an FDA 510(k) clearance for the DeRoyal Laprador Specimen Retrieval System, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on August 17, 2017, 90 days after receiving the submission on May 19, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K171475 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2017
Decision Date	August 17, 2017
Days to Decision	90 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).