TrocaSys
by Pajunk GmbH Medizintechnologie
510(k) K063528
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063528 | Date17 Jan 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GCJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The TrocaSys is a manually operated surgical device classified as a trocars and cannulas under the Gastroenterology and Urology categories. It is designed to create controlled incisions in the patient’s body, facilitating the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures. The device is intended for use in minimally invasive surgical applications where precise tissue penetration and access are required.
TrocaSys is supplied as a reusable medical device and is intended for single-patient use per procedure. It is not specified as MRI-safe or -unsafe in the available data. The device is authorized under FDA 510(k) clearance (K063528) and is manufactured by Pajunk GmbH Medizintechnologie. Storage and handling instructions are not provided in the specifications, but standard surgical device protocols should be followed to maintain sterility and functionality.
Other devices from Pajunk GmbH Medizintechnologie
Questions
AI-generated answers, 1 Oct 2026
What is the TrocaSys device used for?
The TrocaSys is designed to create controlled incisions in the patient’s body, allowing for the insertion of endoscopes and endoscopic accessories. It is specifically intended for use in minimally invasive surgical applications, such as general endoscopic and laparoscopic procedures, where precise tissue penetration and access are critical.
Is the TrocaSys reusable or single-use?
The TrocaSys is classified as a reusable medical device but is intended for single-patient use per procedure. This means it can be used across multiple procedures, provided it is properly cleaned, sterilized, and maintained between uses.
What are the key categories or applications for the TrocaSys?
The TrocaSys falls under the Gastroenterology and Urology categories, as determined by the FDA’s advisory committee. It is particularly suited for procedures requiring controlled access, such as endoscopic and laparoscopic surgeries.
Does the TrocaSys have any specific MRI safety information?
The available data does not specify whether the TrocaSys is MRI-safe or MRI-unsafe. If MRI compatibility is a concern for a procedure, additional verification or manufacturer guidance should be consulted before use.
What regulatory clearance does the TrocaSys hold?
The TrocaSys has received FDA 510(k) clearance under the reference number K063528. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets applicable regulatory requirements.