Cannula, Perfusion, Fallopian Tube
by J. Sklar Mfg. Co., Inc. 510(k)
Active
510(k) K772230
Overview
The Cannula, Perfusion, Fallopian Tube is a uterine manipulator and injector device. It is designed to be inserted into a body cavity or duct for medical purposes.
This device is manufactured by J. Sklar Mfg. Co., Inc. and has received FDA 510(k) clearance under the product code LKF. It is classified as a Class II medical device within the obstetrics and gynecology specialty.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772230 | Date3 Jan 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LKF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from J. Sklar Mfg. Co., Inc.
Questions
What is the primary function of the Fallopian Tube Perfusion Cannula?
This device is designed to serve as a uterine manipulator and injector. It is intended for insertion into a body cavity or duct to facilitate medical procedures within the field of obstetrics and gynecology.
What is the regulatory classification of this device?
The device is classified as a Class II medical device under the obstetrics and gynecology specialty. It has received FDA 510(k) clearance under product code LKF, indicating it has been found substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of this perfusion cannula?
This device is manufactured by J. Sklar Mfg. Co., Inc., located in Walker, Michigan. The company is the applicant of record for the FDA 510(k) clearance associated with this specific cannula model.