Cytoprep System
by Cytoprep Inc. Est. Liechtenstein 510(k)
510(k) K983181
Product code HHI
Overview
The Cytoprep System is a Vacuum Abortion Device, classified as a Class II medical device under FDA regulations. It is designed for use in obstetrics and gynecology to perform aspiration abortions by removing uterine contents through controlled vacuum suction. The system operates under the regulatory framework for reproductive health interventions, adhering to strict safety and performance standards for procedural devices.
This device is supplied as a reusable system, intended for use in clinical settings such as hospitals or outpatient clinics. It is not sterile at the time of shipment but must be sterilized prior to use, typically via autoclave or chemical sterilization methods. The system includes multiple components, each assigned a unique registration number for traceability, and is governed by FDA clearance under the 510(k) pathway. Compliance with regulation number 884.5070 ensures adherence to manufacturing, labeling, and performance requirements for vacuum abortion systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983181 | Date16 Nov 1998 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Cytoprep
- 510(k) Number
- FDA Product Code
- HHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5070
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Cytoprep System used for in obstetrics and gynecology?
The Cytoprep System is designed specifically for performing aspiration abortions in clinical settings. It removes uterine contents through controlled vacuum suction, adhering to FDA standards for reproductive health interventions. This method is commonly used in hospitals or outpatient clinics for first-trimester abortions, ensuring precise and safe procedural outcomes.
Is the Cytoprep System sterile upon delivery, and how should it be prepared for use?
No, the Cytoprep System is not sterile at the time of shipment. Prior to use, it must be sterilized using approved methods such as autoclaving or chemical sterilization. Sterilization ensures patient safety by eliminating contaminants before clinical application, aligning with FDA requirements for reusable medical devices.
How is the Cytoprep System regulated, and what compliance standards apply?
The Cytoprep System is classified as a Class II medical device under FDA regulations and has received 510(k) clearance, demonstrating substantial equivalence to a predicate device. It complies with regulation number 884.5070, covering manufacturing, labeling, and performance standards for vacuum abortion systems. This regulatory pathway ensures the device meets safety and effectiveness criteria for obstetrics/gynecology procedures.
Does the Cytoprep System include traceable components, and how are they identified?
Yes, the Cytoprep System consists of multiple components, each assigned a unique registration number for traceability. These numbers facilitate inventory management, quality control, and compliance tracking, ensuring accountability throughout the device’s lifecycle in clinical settings.
What clinical environments are appropriate for using the Cytoprep System?
The Cytoprep System is intended for use in controlled clinical environments such as hospitals or outpatient clinics equipped to handle reproductive health procedures. Its reusable design and sterilization requirements necessitate facilities with proper sterilization protocols and trained personnel to ensure safe and compliant operation.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K983181