# K090631: Pajunk Disposable Balloons and Balloon Systems

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Apr 16, 2009 after 38 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: 3 generations back to K944418 (1994). 12 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935426: Preperitoneal Distention Balloon System, Origin Medsystems, Inc. (1994). Our reading of the summary gave K936426, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Preperitoneal Distention Balloon System”. Summary page 1.
- K973046: Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak, General Surgical Innovations (1998) Summary page 2.
- K042412: Modified Spacemaker System, United States Surgical, A Division of Tyco Healthc (2004) Summary page 2.

## Most influential descendants
- K092726: Mesh GPS - Large, Small, SM, SM Small (2010), 7 descendants of its own
- K102766: Composix L/P Mesh with Echo PS Positioning System (2010), 6 descendants of its own
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System (2012), 4 descendants of its own
- K130968: Ventralight ST Mesh with Echo PS Positioning System (2013), 3 descendants of its own

## Indications for use
The PAJUNK Balloon systems are 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. The PAJUNK Obturator 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.

Source page: https://510kreport.com/device/K090631
Methodology: https://510kreport.com/methodology