# K151356: Spacemaker Pro Access and Dissector System

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Jun 18, 2015 after 29 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 K042412 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042412: Modified Spacemaker System, United States Surgical, A Division of Tyco Healthc (2004) Summary page 4.

## Indications for use
The Spacemaker™ Pro dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space. The Spacemaker™ Pro blunt tip trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery. The Spacemaker™ Pro structural balloon trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.

Source page: https://510kreport.com/device/K151356
Methodology: https://510kreport.com/methodology