Hatcher Stone Extractor Disposable Catheter
510(k) K862949
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862949 | Date31 Oct 1986 | 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- Withdrawn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
- LQR
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5010
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hatcher Stone Extractor Disposable Catheter is a dislodger, stone, biliary device, classified under FDA product code LQR. It is designed to mechanically fragment and remove biliary or urinary stones within the body, facilitating their extraction via catheterization. The device operates through a controlled mechanical action to break down stones into smaller fragments that can be safely retrieved, reducing the risk of obstruction or injury during the procedure.
This single-use catheter is intended for use in gastroenterology and urology settings, where it is inserted into the biliary or urinary tract under direct visualization. Supplied sterile and packaged for one-time use, it requires no special storage conditions beyond standard medical device handling. The device has been cleared through the FDA 510(k) pathway as substantially equivalent to prior-generation technology, adhering to regulatory standards for Class II medical devices. No MRI safety considerations are specified, and its use is restricted to trained professionals in clinical environments.
Other devices from Oscor Medical Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Hatcher Stone Extractor Disposable Catheter used for?
The Hatcher Stone Extractor Disposable Catheter is designed to mechanically fragment and remove biliary or urinary stones within the body. It operates through controlled mechanical action to break stones into smaller fragments, allowing safe retrieval via catheterization. This reduces the risk of obstruction or injury during procedures, making it suitable for use in gastroenterology and urology settings.
Is the Hatcher Stone Extractor Disposable Catheter single-use or reusable?
The Hatcher Stone Extractor Disposable Catheter is explicitly designed for single-use only. It is supplied sterile and packaged for one-time clinical use, ensuring patient safety and compliance with medical device standards.
What are the storage requirements for this device?
The Hatcher Stone Extractor Disposable Catheter requires no special storage conditions beyond standard medical device handling. Since it is sterile and single-use, it should be stored in its original packaging until ready for use, following general medical device storage guidelines to maintain integrity.
Can this device be used with MRI equipment?
The device documentation does not specify any MRI safety considerations, meaning it has not been tested or validated for use in MRI environments. As a result, its use should be restricted to non-MRI settings to avoid potential risks.
Who should operate the Hatcher Stone Extractor Disposable Catheter?
The Hatcher Stone Extractor Disposable Catheter is intended for use by trained professionals in clinical environments. Its design and mechanical action require expertise in gastroenterology or urology to ensure proper insertion, fragmentation, and retrieval of stones safely and effectively.