510(k) · Cleared
ClearedA-Lap Set (a-Lap, Ezaxess, Trocar)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ezsurgical · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 2, 2009 as substantially equivalent to K914190 (United States Surgical, A Division of Tyco Healthc, 1992) and 1 other predicate after a 144-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jan 2, 2009
- Review
- 144 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914190 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK914190 Auto Suture (R) Endoscopic Fan RetractorUnited States Surgical, A Division of Tyco Healthc · 1992
- This deviceK082291 A-Lap Set (a-Lap, Ezaxess, Trocar)Ezsurgical · 2009
- Descendant · cites it directly · 0 of its ownK153542 Pelican Sling RetractorBeacon Surgical, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153542Pelican Sling RetractorBeacon Surgical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914190 | Auto Suture (R) Endoscopic Fan Retractor | United States Surgical, A Division of Tyco Healthc | 1992 | — |
| 0 (this device) | K082291 | A-Lap Set (a-Lap, Ezaxess, Trocar) | Ezsurgical | 2009 | — |
| +1 | K153542 | Pelican Sling Retractor | Beacon Surgical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K914190 | Auto Suture (R) Endoscopic Fan RetractorSummary page 2…s are substantially equivalent to the following predicate devices: * Autosuture endoscopic Fan retractor (United States Surgical corporation); cleared under K914190. Autosuture Endo paddle retractor (Autosuture); 510(k) exempt. Autosuture VersaportPlus Bladeless Trocar (Tyco He… | 1992 |
| * | K081169 | Autosuture Versaport Plus Bladless Trocar; Bladeless TrocarSummary page 2…0. Autosuture Endo paddle retractor (Autosuture); 510(k) exempt. Autosuture VersaportPlus Bladeless Trocar (Tyco Healthcare Group); cleared under k081169. Device Description: The A LapTM set is laparoscopic surgical device compose of two components: A-LapTM Retractor - a surgical… | 2008 |
| * | — | Autosuture Endo paddle retractor Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153542 | Pelican Sling Retractor | 2016 | 0 |
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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 A-LapTM set has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The set may be used in procedures to create and maintain a port of entry and for temporary retracting of tissue.
The A-Lapm retractor has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The device may be used in procedures requiring temporary retracting of tissue.
The EZaxess is intended for use in creating and maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082291: A-Lap Set (a-Lap, Ezaxess, Trocar).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082291
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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