HT4-SERIES Hysteroscopes and Accessories
510(k) K905392
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905392 | Date30 Apr 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1690
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The HT4-Series Hysteroscopes and Accessories are diagnostic and therapeutic devices classified as hysteroscopes (and accessories) under FDA classification HIH. Hysteroscopes are endoscopes used to visualize the interior of the uterus, enabling direct inspection, diagnosis, and treatment of uterine conditions such as polyps, fibroids, or structural abnormalities. These devices incorporate optical systems, irrigation channels, and working channels for instrument insertion, facilitating minimally invasive gynecological procedures.
The HT4-Series Hysteroscopes and Accessories are intended for use in clinical settings such as outpatient clinics, hospitals, and surgical centers. They are regulated under FDA 510(k) clearance (K905392) and fall under regulation number 884.1690. The series includes multiple model references, ensuring compatibility with various procedural needs. Usage may involve single-use or reusable components, and compliance with relevant standards for sterility and MRI safety would be required for clinical use.
HT4-Series Hysteroscopes and Accessories
Other devices from Frigitronics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the HT4-Series Hysteroscopes?
The HT4-Series Hysteroscopes are designed for diagnostic and therapeutic procedures in gynecology. They allow clinicians to visualize the interior of the uterus directly, enabling the identification and treatment of conditions such as polyps, fibroids, and structural abnormalities. The devices incorporate optical systems, irrigation channels, and working channels to facilitate minimally invasive interventions.
Are the HT4-Series Hysteroscopes single-use or reusable?
The HT4-Series Hysteroscopes can include both single-use and reusable components, depending on the specific model and accessories selected. Sterility and MRI safety compliance must be ensured for clinical use, so proper handling and processing protocols are essential to maintain device integrity and patient safety.
What types of clinical settings can use the HT4-Series Hysteroscopes?
These hysteroscopes are intended for use in clinical settings such as outpatient clinics, hospitals, and surgical centers. Their versatility and compatibility with various procedural needs make them suitable for environments where minimally invasive gynecological procedures are performed.
How many model references are available in the HT4-Series?
The HT4-Series includes multiple model references, each designed to meet specific procedural requirements. These variations ensure compatibility with a range of clinical scenarios, allowing clinicians to select the appropriate device for their patients’ needs.
What regulatory pathway does the HT4-Series Hysteroscopes follow?
The HT4-Series Hysteroscopes are regulated under the FDA 510(k) clearance pathway, specifically classified under regulation number 884.1690. They were cleared through a traditional 510(k) submission, with the decision determined by the Obstetrics/Gynecology Advisory Committee, and are classified as substantially equivalent to predicate devices.