# K082291: A-Lap Set (a-Lap, Ezaxess, Trocar)

- Pathway: 510(k) (Traditional)
- Applicant: Ezsurgical
- Decided: Jan 2, 2009 after 144 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914190 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914190: Auto Suture (R) Endoscopic Fan Retractor, United States Surgical, A Division of Tyco Healthc (1992) Summary page 2.
- K081169: Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar, Covidien Lp, Formerly Registered AS United States (2008) Summary page 2.
- (no number) Autosuture Endo paddle retractor: named in the summary without a submission number

## Most influential descendants
- K153542: Pelican Sling Retractor (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K082291
Methodology: https://510kreport.com/methodology