Fertiloscopy Kit FH 1.29/FTO 1.40
by Soprane S.A.
510(k) K992655
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992655 | Date13 Mar 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HEW
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1640
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Fertiloscopy Kit FH 1.29/FTO 1.40 is a Culdoscope (and Accessories), a diagnostic device used in obstetrics and gynecology to visually inspect the peritoneal cavity, fallopian tubes, and ovaries. It facilitates the evaluation of tubal patency, ovarian function, and peritoneal pathology, aiding in fertility assessments and diagnostic procedures.
This kit is supplied as a reusable medical device and is intended for use in clinical settings under sterile conditions. It includes components such as the culdoscope, accessories, and associated instrumentation, with regulatory clearance under 21 CFR §884.1640 as a Class II device. The kit is authorized for distribution in the United States following FDA 510(k) clearance (K992655) via the Traditional pathway, adhering to obstetrics/gynecology standards.
Questions
AI-generated answers, 19 Sep 2026
What clinical specialties primarily use the Fertiloscopy Kit FH 1.29/FTO 1.40, and how does it assist in patient evaluation?
The Fertiloscopy Kit FH 1.29/FTO 1.40 is designed for use in obstetrics and gynecology, where it aids in diagnosing fertility-related conditions. It allows clinicians to visually inspect the peritoneal cavity, fallopian tubes, and ovaries to assess tubal patency, ovarian function, and peritoneal pathology—key factors in fertility assessments and diagnostic procedures.
Is the Fertiloscopy Kit FH 1.29/FTO 1.40 intended for single-use or reusable applications, and how should it be handled?
The kit is explicitly labeled as a reusable medical device, meaning it is designed for repeated use in clinical settings. Since it is intended for sterile procedures, it must be properly cleaned, sterilized, and maintained according to established medical device reprocessing protocols to ensure patient safety and device integrity.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in the U.S.?
The Fertiloscopy Kit FH 1.29/FTO 1.40 received FDA clearance via the Traditional 510(k) pathway under 21 CFR §884.1640, classified as a Class II device. This means its safety and effectiveness were compared to a legally marketed predicate device, confirming it is substantially equivalent to existing culdoscope systems. It is authorized for distribution in the U.S. following clearance under K992655 and adheres to obstetrics/gynecology standards.
What types of accessories or instrumentation are included in the Fertiloscopy Kit FH 1.29/FTO 1.40, and how do they contribute to its diagnostic capabilities?
While the exact accessories aren’t detailed, the kit includes a culdoscope (the primary diagnostic tool) along with associated instrumentation to facilitate peritoneal cavity visualization. These components enable clinicians to evaluate fallopian tube patency, ovarian health, and peritoneal conditions—critical for fertility diagnostics. The full scope of accessories would be outlined in the manufacturer’s instructions for use.