QWIK-CALL
by Emde Corp.
510(k) K860052
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860052 | Date6 Feb 1986 | 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- Withdrawn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
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The QWIK-CALL is a medical device classified under product code KNT, designed as a urinary catheter retrieval device. It is intended for the removal of indwelling urinary catheters, particularly in cases where standard extraction methods are ineffective or impractical. Constructed for clinical use in urological procedures, it aids in safely retrieving catheters without causing trauma to surrounding tissues.
Supplied as a single-use device, the QWIK-CALL is intended for use in clinical settings such as hospitals and outpatient care facilities. Its design adheres to FDA clearance under 510(k) number K860052, with a decision of Substantially Equivalent (SE) following review by the Gastroenterology and Urology Advisory Committee. No specific sterility or MRI safety information is provided in the regulatory data. Storage and handling instructions are not detailed beyond standard single-use medical device protocols.
Other devices from Emde Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the QWIK-CALL used for?
The QWIK-CALL is designed specifically for the retrieval of indwelling urinary catheters in clinical settings. It is intended for use when traditional extraction methods are ineffective or pose a risk of tissue trauma, making it particularly useful in urological procedures where catheter removal must be performed carefully.
Is the QWIK-CALL a single-use or reusable device?
The QWIK-CALL is supplied as a single-use device. This ensures sterility and safety for each patient, adhering to standard medical device protocols for clinical use in hospitals and outpatient care facilities.
What regulatory clearance does the QWIK-CALL hold?
The QWIK-CALL holds FDA clearance under the 510(k) process, with clearance number K860052. It was reviewed by the Gastroenterology and Urology Advisory Committee and determined to be Substantially Equivalent (SE) to a predicate device, allowing it to enter the market legally for its intended use.
Where can the QWIK-CALL be used?
The QWIK-CALL is intended for use in clinical settings such as hospitals and outpatient care facilities. Its design and single-use nature make it suitable for controlled environments where sterile procedures are required.
Are there any specific storage instructions for the QWIK-CALL?
The regulatory data does not provide detailed storage instructions beyond standard protocols for single-use medical devices. It is recommended to follow general guidelines for maintaining the integrity of the packaging until use, ensuring no contamination or damage occurs.