Identity
- Trade Name
- FILSHIE CLIP (MARK VI) SYSTEM FDA PMA
- Generic Name
- Laparoscopic contraceptive tubal occlusion device FDA PMA
Identifiers
- PMA Number
- P920046 FDA PMA
- FDA Product Code
- KNH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 884.5380 FDA PMA
- Regulation Number
- 884.5380 FDA PMA
- Advisory Committee
- Obstetrics/Gynecology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Filshie Clip (Mark VI) System is a Laparoscopic Contraceptive Tubal Occlusion Device (TOD), classified as a Class III medical device under FDA regulations. It is designed for permanent sterilisation by occluding the fallopian tubes laparoscopically, preventing sperm from reaching the egg and thereby achieving contraception.
This system is supplied sterile and intended for single-use in a controlled surgical setting. It is approved for use in obstetrics/gynecology procedures and adheres to FDA PMA (Premarket Approval) requirements under docket number 96M-0463. The device is regulated under FDA regulation number 884.5380 and includes multiple FEI numbers for tracking and identification.
Frequently asked questions
What is the primary purpose of the Filshie Clip (Mark VI) System and how does it work?
The Filshie Clip (Mark VI) System is designed for permanent contraception by laparoscopically occluding the fallopian tubes. It achieves this by placing clips around the tubes, physically blocking sperm from reaching the egg, thereby preventing fertilization. This method is intended for use in obstetrics/gynecology procedures as a long-term contraceptive solution.
Is the Filshie Clip (Mark VI) System intended for single-use or reusable, and how is it supplied?
The Filshie Clip (Mark VI) System is explicitly intended for **single-use only** and is supplied sterile. This ensures patient safety and compliance with surgical best practices, as reuse could compromise sterility and effectiveness.
What regulatory pathway does the Filshie Clip (Mark VI) System follow, and what does this mean for clinicians?
The Filshie Clip (Mark VI) System follows the **FDA Premarket Approval (PMA)** pathway, as indicated by its PMA number (P920046) and docket number (96M-0463). This means the device underwent rigorous review by the FDA to ensure safety and effectiveness for its intended use in permanent contraception via tubal occlusion. Clinicians can rely on this approval as evidence of the device’s compliance with stringent regulatory standards.
How are the different sizes or models of the Filshie Clip (Mark VI) System identified, and why does this matter?
The Filshie Clip (Mark VI) System includes multiple **FEI numbers** (e.g., 3002807314, 1314417) and registration numbers for tracking and identification. These identifiers help clinicians and facilities distinguish between variants, ensuring proper inventory management and correct application during laparoscopic procedures. While the exact sizes or models aren’t detailed here, the FEI numbers are tied to regulatory tracking for traceability and compliance.
What surgical setting is the Filshie Clip (Mark VI) System intended for, and what precautions should be taken during use?
The Filshie Clip (Mark VI) System is designed for use in a **controlled surgical setting**, specifically during laparoscopic procedures in obstetrics/gynecology. Since it is single-use and sterile, precautions must include maintaining aseptic techniques, proper handling to avoid contamination, and adherence to sterile field protocols to prevent infection or complications during the procedure.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P920046 | Class III | Active |
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Manufacturer
- Manufacturer
- Femcare , Ltd.
Sources (1)
- FDA PMA P920046 24 fields · synced Sep 18, 2026