# K070651: Aragon Surgical Lapcap

- Pathway: 510(k) (Traditional)
- Applicant: Aragon Surgical, Inc.
- Decided: May 30, 2007 after 82 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852726 (1985). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061387: Veresure Bell, Veresure, Inc. (2006) Summary page 1.
- K003703: Taut-Insufflation Needle, Taut, Inc. (2001) Summary page 1.

## Most influential descendants
- K233020: TauTona Pneumoperitoneum Assist Device (TPAD) (2024), 1 descendant of its own
- K073452: Modification to: Aragon Surgical Lapcap (2008), 1 descendant of its own
- K242536: TauTona Pneumoperitoneum Assist Device (TPAD) (2024), 0 descendants of its own
- K212786: LevaLap Laparoscopic Access Device (2022), 0 descendants of its own

## Indications for use
The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.

Source page: https://510kreport.com/device/K070651
Methodology: https://510kreport.com/methodology