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Pelican Sling Retractor

by Beacon Surgical, Inc.

510(k) K153542

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 NumberK153542 Date7 Sep 2016ClearedStatusActive

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  • Withdrawn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, 25 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 Pelican Sling Retractor is a surgical instrument for temporary tissue or organ retraction. It consists of a shaft with a blunt tip, a deployment dial, and a flexible polymer mesh or film sling. The device is used for retraction during surgical procedures.

The Pelican Sling Retractor is a sterile, single-use device. It is supplied in various configurations and is classified under product code GCJ. The device has been found to be substantially equivalent and has received FDA 510K clearance, with the decision date being 2016-09-07.

Other devices from Beacon Surgical, Inc.