Boehringer Laboratories, LLC · Class II · Cleared Jul 2, 2025
| K-number | K243399 |
| Device name | Boehringer Laboratories Liver Retractor |
| Applicant | Boehringer Laboratories, LLC |
| Product code | GCJ |
| Device class | Class II |
| Decision date | Jul 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Boehringer Laboratories Liver Retractor is a laparoscopic surgical device comprising a soft polyurethane cup connected to flexible suction tubing, a positioning clip, and an integral suction regulator. It is indicated for use in laparoscopic procedures to elevate the liver, improve access to surgical sites, and provide visualization of target anatomy during surgery.
The subject device shares suction-based operation and conformable materials with the predicate LiVac® Retractor System. Key differences include: the subject device uses a non-adjustable integral suction regulator factory-set to 280–360 mmHg, whereas the predicate uses user-adjusted external regulation at 300–600 mmHg; the subject device uses a polyurethane cup with embedded foam and flexible tubing, while the predicate uses a soft silicone ring; and the subject device includes an external nylon positioning clip not present in the predicate design.
ISO 10993-1, -5, -10, -11, -23 (biocompatibility); ISO 11137-1, -2, -3 and ISO 11373-1, -2 (sterilization validation); ASTM D4332, D7386, F2096, F88/F88M (packaging integrity); GLP-compliant live animal safety study; performance testing for device retraction times; device integrity and regulator functionality testing; and accelerated shelf-life/stability testing.
The subject device shares the same regulatory classification (Class II, 21 CFR 876.1500), intended use (laparoscopic retraction to elevate organs and improve surgical access), and fundamental operating principle (suction-based retraction) as the predicate. Although the subject device incorporates a factory-set integral regulator and differs in materials and clip design, bench testing and animal safety studies demonstrated equivalent function, safety, and effectiveness to the predicate. The narrower intended use (liver only versus liver and other organs) and lower, non-adjustable suction setpoint do not raise new safety or effectiveness questions and remain within the scope of the predicate's laparoscopic retraction technology.
View the full FDA submission: accessdata.fda.gov