MODULAR LAPAROSCOPY ACCESSORIES, HANDLE - Modular Laparoscopy Accessories, Handle
510(k) K062337
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062337 | Date5 Oct 2006 | 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- Withdrawn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
- GEI
- Models / Variants
- Modular Laparoscopy Accessories, Handle
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device comprises modular laparoscopic accessories designed for minimally invasive surgical procedures. It includes a handle, straight and curved scissors, and various graspers—aggressive, Allis, atraumatic, and dissectors—each tailored for precise tissue manipulation, dissection, and cutting within laparoscopic environments. The modular design allows for flexible configuration based on surgical requirements, enhancing adaptability during procedures. These instruments are classified under general plastic surgery applications and are intended for use in laparoscopic surgery settings.
The accessories are supplied as reusable surgical instruments, requiring proper sterilization between uses in accordance with standard medical protocols. They are designed for use in non-MRI environments and must be handled with care to maintain sterility and functionality. Sizes and configurations are standardized to fit common laparoscopic ports and instruments, ensuring compatibility with existing surgical systems. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K062337), these instruments adhere to regulatory standards for surgical tools in minimally invasive procedures.
Other devices from Aaron Medical Industries
Questions
AI-generated answers, 20 Sep 2026
Are these laparoscopic accessories designed for single-use or can they be reused after proper sterilization?
These instruments are reusable and must be sterilized between uses following standard medical protocols to ensure safety and functionality. The manufacturer explicitly states they require proper sterilization, which is typical for reusable surgical tools.
What types of graspers are included in this modular laparoscopic accessory set, and how do they differ in function?
The set includes five types of graspers: aggressive (for firm tissue grip), Allis (for securing tissue without slipping), atraumatic (to minimize tissue damage), and dissectors (for precise tissue separation). Each is designed for specific surgical needs during minimally invasive procedures.
Can these instruments be used in an MRI environment, or are they restricted to non-MRI settings?
These instruments are not approved for MRI environments. The manufacturer explicitly notes they are designed for use in non-MRI settings only, so caution must be taken to avoid exposure to magnetic fields.
How do I know if these accessories will fit with my existing laparoscopic ports and systems?
The instruments are standardized to fit common laparoscopic ports and systems, ensuring compatibility with widely used surgical setups. However, verifying exact measurements or consulting the manufacturer’s sizing guides is recommended to confirm fit with your specific equipment.
What regulatory pathway was followed for FDA clearance of these laparoscopic accessories?
These instruments received FDA 510(k) clearance (K062337) under the Traditional 510(k) Review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. The review was conducted by the Surgical and Urological Devices (SU) Advisory Committee under product code GEI (General Plastic Surgery).