Geenen/Zebra Guidelines
510(k) K942677
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942677 | Date21 Jul 1994 | 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- Withdrawn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
- FDE
- FDA applicant
- Boston Scientific Corp
- 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 Geenen Zebra Guidelines Laparoscopy Kit is a laparoscopy kit designed for minimally invasive surgical procedures. It includes a range of instruments and accessories intended to assist in diagnostic and therapeutic interventions within the abdominal or pelvic cavities, primarily in gastroenterology and urology. The kit is structured to support precise visualization and manipulation of tissues, aiding in procedures such as biopsies, suturing, or the removal of pathological specimens.
This kit is supplied as a sterile, single-use device and is intended for use in elective surgical settings under controlled conditions. It adheres to FDA 510(k) clearance (K942677) under the classification of Laparoscopy Kit (FDE, Regulation 876.1500). The included instruments are designed for non-MRI environments and must be stored in accordance with manufacturer guidelines to maintain sterility and functionality. No reusable components are specified, and the kit is not intended for reuse.
Other devices from Boston Scientific
Questions
AI-generated answers, 1 Oct 2026
What is the Geenen Zebra Guidelines Laparoscopy Kit used for?
The Geenen Zebra Guidelines Laparoscopy Kit is designed for minimally invasive surgical procedures within the abdominal or pelvic cavities. It supports diagnostic and therapeutic interventions such as biopsies, suturing, and removal of pathological specimens, primarily in the fields of gastroenterology and urology. The kit’s instruments are structured to provide precise visualization and manipulation of tissues, making it suitable for controlled elective surgical settings.
Is the Geenen Zebra Guidelines Laparoscopy Kit sterile and single-use?
Yes, the kit is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintains the integrity of the instruments for a single surgical procedure. Reuse is not intended or recommended, as outlined by the manufacturer’s guidelines.
What special considerations are there for storing this kit?
The kit must be stored in accordance with the manufacturer’s guidelines to preserve sterility and functionality. Since it is intended for non-MRI environments, proper storage conditions—such as avoiding exposure to moisture, extreme temperatures, or physical damage—are critical. Adhering to these instructions ensures the instruments remain effective for their intended use.
Does this kit include reusable components?
No, the Geenen Zebra Guidelines Laparoscopy Kit is designed as a fully disposable device with no reusable components. This aligns with best practices for minimizing infection risks and maintaining consistency in surgical outcomes.
What regulatory clearance does this kit hold?
The kit holds FDA 510(k) clearance under the classification of Laparoscopy Kit (FDE, Regulation 876.1500), with the clearance number K942677. This indicates it has been deemed substantially equivalent to a legally marketed predicate device, meeting the regulatory requirements for use in the United States.