Tenckhoff Peritoneal Tubing Adapt
by Quinton, Inc. 510(k)
Active
510(k) K771428
Overview
The Tenckhoff Peritoneal Tubing Adapt is a connector, tubing, dialysate device, classified as a medical device in the field of Gastroenterology and Urology. It is used in peritoneal dialysis. The device is substantially equivalent to other devices on the market.
The device is supplied by Quinton, Inc. and has been cleared under FDA 510K number K771428. It is classified as a class 2 device with regulation number 876.5820. The device has a product code of FKY and is used in medical settings, with specific storage and handling requirements not specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771428 | Date18 Oct 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FKY
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What is the Tenckhoff Peritoneal Tubing Adapt used for?
The Tenckhoff Peritoneal Tubing Adapt is used in peritoneal dialysis, a medical treatment that filters waste products from the blood when the kidneys are no longer able to perform this function.
How is the device supplied?
The device is supplied by Quinton, Inc., and is intended for use in medical settings.
What are the storage and handling requirements for the device?
The specific storage and handling requirements for the Tenckhoff Peritoneal Tubing Adapt are not specified in the provided data, but it is classified as a class 2 device with regulation number 876.5820.
Is the device sterile?
The provided data does not specify whether the Tenckhoff Peritoneal Tubing Adapt is supplied sterile or non-sterile.