Faller Trocar
510(k) K120130
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120130 | Date21 May 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Faller Trocar is a catheter, peritoneal, long-term indwelling (per FDA classification), designed to create an antegrade subcutaneous tunnel for peritoneal dialysis catheters. It facilitates the passage of the catheter from the initial implantation site to the exit site on the skin, minimizing tissue trauma during tunneling. Constructed with a stainless steel or plastic design, it offers two distinct shapes—one resembling the Covidien Trocar and the other the Medigroup Tunnelor Tool—to accommodate surgeon preference. Its primary function is to guide and separate tissue as the catheter is advanced beneath the skin.
The Faller Trocar is supplied as a sterile, single-use device intended for surgical use in peritoneal dialysis catheter implantation. It is classified as a Class II medical device under FDA regulations (21 CFR 876.5630) and was cleared via a Traditional 510(k) pathway (K120130) with a Substantially Equivalent determination by the Gastroenterology and Urology (GU) Advisory Committee. No MRI safety information is specified, and its reusable or disposable nature is not detailed in the regulatory data. Storage and handling must comply with standard sterile surgical instrument protocols.
Other devices from Medigroup
Questions
AI-generated answers, 1 Oct 2026
What is the Faller Trocar used for in peritoneal dialysis procedures?
The Faller Trocar is designed to create an antegrade subcutaneous tunnel during peritoneal dialysis catheter implantation. It guides the catheter from the initial insertion site to the exit point on the skin, minimizing tissue damage by separating and separating tissue layers as the catheter is advanced. This reduces trauma and improves catheter placement accuracy.
How is the Faller Trocar supplied, and what are its sterility and reuse specifications?
The Faller Trocar is supplied as a sterile, single-use device intended exclusively for surgical use. While the regulatory data does not explicitly confirm its reusable nature, the standard practice for tunneling tools in peritoneal dialysis aligns with single-use protocols to prevent infection and contamination. Always follow sterile surgical instrument protocols for storage and handling.
Are there different shapes or models of the Faller Trocar, and why?
Yes, the Faller Trocar comes in two distinct shapes: one resembling the Covidien Trocar and another designed like the Medigroup Tunnelor Tool. These variations accommodate surgeon preference, allowing for flexibility in tunneling techniques based on familiarity and procedural needs.
What materials is the Faller Trocar constructed from?
The Faller Trocar is constructed from either stainless steel or plastic, depending on the specific model or variant. The material choice ensures durability and ease of use during the tunneling process while maintaining compatibility with surgical environments.
How should the Faller Trocar be stored to maintain sterility?
The Faller Trocar must be stored according to standard sterile surgical instrument protocols. Since it is a single-use device, it should remain in its original, unopened packaging until immediately before use. Avoid exposure to moisture, heat, or contamination, and adhere to manufacturer guidelines for shelf life and handling to preserve sterility.