Skip to content

DeRoyal Laprador Specimen Retrieval System

by Deroyal Industries, Inc.

510(k) K171475

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171475 Date17 Aug 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GCJ
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DeRoyal Laprador Specimen Retrieval System is a sterile laparoscopic retrieval device designed for the collection and extraction of tissue, organs, and calculi during minimally invasive surgical procedures. It falls under the category of specimen retrieval systems, facilitating safe and contained removal of specimens from the patient’s body.

The system comprises a handle, cylindrical tube, string, and ripstop nylon bag, supplied in sterile packaging for single-use. It is intended for use in laparoscopic settings and has received FDA 510(k) clearance under the Gastroenterology and Urology advisory committees. Each case contains five retrieval bags, ensuring compatibility with minimally invasive procedures.

Other devices from Deroyal Industries, Inc.

See all devices from Deroyal Industries, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of specimens can the DeRoyal Laprador Specimen Retrieval System safely collect during surgery?

    The DeRoyal Laprador Specimen Retrieval System is designed for the safe collection and extraction of tissue, organs, and calculi (such as kidney stones) during minimally invasive laparoscopic procedures. Its sealed ripstop nylon bag and retrieval mechanism ensure contained removal from the patient’s body.

  • Is the DeRoyal Laprador Specimen Retrieval System reusable, or is it intended for single-use only?

    The system is explicitly supplied in sterile packaging and is intended for single-use only. Each case includes five retrieval bags, ensuring compliance with sterile procedure requirements and preventing cross-contamination between patients.

  • How many retrieval bags are included in a single case of the DeRoyal Laprador Specimen Retrieval System, and what is their purpose?

    Each case contains five sterile retrieval bags, which are designed to securely contain specimens (tissue, organs, or calculi) during laparoscopic extraction. The bags are part of the system’s cylindrical tube and string assembly, ensuring compatibility with minimally invasive procedures.

  • What regulatory pathway did the DeRoyal Laprador Specimen Retrieval System follow to gain market authorization in the U.S.?

    The device received FDA 510(k) clearance under the Gastroenterology and Urology advisory committees, classified as substantially equivalent (SESE) to a predicate device. The submission was reviewed by the GU (Gastroenterology/Urology) panel and filed under product code GCJ (Gastroenterology/Urology instruments).

  • How is the DeRoyal Laprador Specimen Retrieval System packaged, and what precautions should be taken during storage?

    The system is supplied in sterile packaging to maintain integrity for single-use. Storage should follow manufacturer guidelines to preserve sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid opening the packaging until immediate preoperative use to prevent contamination.