Core-Sport
510(k) K220081
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220081 | Date28 Sep 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OTJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Core-Sport is a Laparoscopic Single Port Access Device, designed to facilitate minimally invasive surgical procedures in gastroenterology and urology. It functions as a disposable system that opens and enlarges the incision site, providing a passage for surgical instruments while maintaining a stable working channel during laparoscopy.
This device is supplied as a single-use, disposable system consisting of a Port-Assay and a Retractor. It is classified under FDA regulation number 876.1500 and has received FDA 510(k) clearance (K220081) as a Class II medical device. The Core-Sport is intended for use in sterile surgical environments and is not MRI-compatible. Storage and handling must comply with standard sterile medical device protocols.
Other devices from Incore Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of surgical procedures is the Core-Sport designed to assist with, and why is it particularly useful in minimally invasive surgery?
The Core-Sport is specifically designed for minimally invasive laparoscopic procedures in gastroenterology and urology. It functions as a single-port access device, creating a stable working channel through a single incision, which reduces trauma, shortens recovery time, and minimizes scarring compared to traditional multi-port laparoscopy. Its disposable design ensures sterility and simplifies setup for these specialized fields.
Is the Core-Sport reusable, or is it intended for single-use only? How does this impact its use in sterile surgical environments?
The Core-Sport is explicitly single-use and disposable, meaning each system is intended for one surgical procedure only. This design choice eliminates the risk of cross-contamination between patients and ensures compliance with sterile surgical protocols, as it must be discarded after use. The manufacturer emphasizes its use in sterile environments to maintain safety and efficacy.
What components does the Core-Sport system include, and how is it packaged for surgical use?
The Core-Sport system consists of two main components: a Port-Assay (the main access port) and a Retractor (used to enlarge the incision site). It is supplied as a complete, sterile, single-use disposable system, ready for immediate use in laparoscopic procedures. The packaging adheres to standard sterile medical device protocols to preserve integrity until deployment.
Are there different sizes or models of the Core-Sport, and if so, how might a clinician determine the appropriate one for a patient?
The provided data does not specify distinct sizes or models of the Core-Sport beyond its classification as a Laparoscopic Single Port Access Device. Selection would typically depend on the surgeon’s preference, patient anatomy, and the specific procedure (e.g., gastroenterology vs. urology). Clinicians should consult the manufacturer’s instructions or surgical guidelines for guidance, as sizing details are not explicitly outlined in the regulatory submission.
Can the Core-Sport be used in conjunction with MRI imaging, or are there any restrictions related to its materials?
The Core-Sport is not MRI-compatible, meaning it should not be used in procedures involving MRI imaging. This restriction is likely due to the materials used in its construction, which could interfere with MRI equipment or pose safety risks during scanning. Surgeons must ensure alternative imaging modalities are used if MRI is required post-procedure.