510(k) · Cleared
ClearedPelican Sling Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beacon Surgical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 7, 2016 as substantially equivalent to K082291 (Ezsurgical, 2009) after a 271-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Sep 7, 2016
- Review
- 271 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914190 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914190 | Auto Suture (R) Endoscopic Fan Retractor | United States Surgical, A Division of Tyco Healthc | 1992 | — |
| −1 | K082291 | A-Lap Set (a-Lap, Ezaxess, Trocar) | Ezsurgical | 2009 | — |
| 0 (this device) | K153542 | Pelican Sling Retractor | Beacon Surgical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082291 | A-Lap Set (a-Lap, Ezaxess, Trocar)Summary page 5…dicate Device: The following devices have been identified as a predicate device: The A-Lap™ Set, the A-Lap™ Retractor and EZaxess (EZ Surgical) K082291. Covidien: Auto suture Endo paddle retractor (Auto suture); 510(k) exempt.… | 2009 |
| * | — | Covidien: Auto suture Endo paddle retractor (Auto suture) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Pelican Sling Retractors have applications in a variety of gynecologic, general, urologic, thoracic, colorectal, laparoscopic and endoscopic procedures for the temporary retracting of internal structures such as organs or tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153542: Pelican Sling Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153542
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026