Laminaria
by Cti Corp., Ltd. 510(k)
Active
510(k) K955072
Overview
The Laminaria is a Cervical Dilator, Hygroscopic-Laminaria, classified under FDA product code HDY. It is designed as a cervical dilator made from hygroscopic material, intended to gradually soften and dilate the cervix through absorption of vaginal fluids, facilitating preparation for procedural interventions such as dilation and curettage or labor induction.
Supplied as a single-use device, the Laminaria is regulated under FDA 510(k) clearance (K955072) and falls under Class II medical device classification. It is intended for obstetric and gynecologic use, with no specific MRI safety or sterility requirements stated beyond standard single-use medical device protocols. Storage should follow manufacturer guidelines to maintain efficacy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955072 | Date22 May 1996 | 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- Withdrawn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
- HDY
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4260
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Laminaria used for in clinical practice and how does it work?
The Laminaria is a cervical dilator made from hygroscopic material designed to gradually soften and widen the cervix by absorbing vaginal fluids. This process helps prepare the cervix for procedures like dilation and curettage or labor induction, making it useful in obstetric and gynecologic settings.
Is the Laminaria intended for reuse or is it a single-use device?
The Laminaria is explicitly supplied as a single-use device, meaning it is intended for one-time use only and should not be reused after application. This aligns with standard medical device protocols for sterility and safety.
How should the Laminaria be stored to ensure it remains effective?
While the data does not specify exact storage conditions, the manufacturer’s guidelines should be followed to maintain the device’s efficacy. Generally, single-use medical devices like the Laminaria should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.
What regulatory pathway was followed for the Laminaria’s approval, and what class does it fall under?
The Laminaria was cleared through the FDA’s 510(k) pathway (traditional review) under clearance number K955072 and is classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device and falls under product code HDY for cervical dilators.