Nezhat-Dorsey Laparoscopic Hand Instruments
by American Hydro-Surgical Instruments, Inc. 2 variants
510(k) K950499
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950499 | Date16 Jun 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4160
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Nezhat-Dorsey Laparoscopic Hand Instruments are endoscopic, unipolar coagulator-cutters designed for minimally invasive surgical procedures. These instruments are intended for precise tissue manipulation, coagulation, and cutting within laparoscopic settings, supporting procedures in obstetrics and gynecology. Their design facilitates controlled dissection and hemostasis during minimally invasive surgeries, enhancing surgical precision and reducing trauma to surrounding tissues.
These instruments are supplied as reusable medical devices and are intended for use in sterile environments. They are classified as Class II devices under FDA regulations (product code KNF) and have received FDA 510(k) clearance through the Traditional pathway. The instruments are regulated under the regulation number 884.4160 and are manufactured by American Hydro-Surgical Instruments, Inc. No specific MRI safety information is provided in the available data.
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Questions
AI-generated answers, 1 Oct 2026
What are the Nezhat-Dorsey Laparoscopic Hand Instruments designed for?
These instruments are designed for minimally invasive surgical procedures, specifically for precise tissue manipulation, coagulation, and cutting within laparoscopic settings. They are particularly suited for procedures in obstetrics and gynecology, where controlled dissection and hemostasis are critical to reducing trauma to surrounding tissues and enhancing surgical precision.
Are the Nezhat-Dorsey Laparoscopic Hand Instruments reusable or single-use?
The Nezhat-Dorsey Laparoscopic Hand Instruments are supplied as reusable medical devices. They are intended for use in sterile environments, which means they must be properly cleaned, sterilized, and maintained between uses to ensure safety and efficacy.
What regulatory pathway was followed for FDA clearance of these instruments?
The Nezhat-Dorsey Laparoscopic Hand Instruments received FDA 510(k) clearance through the Traditional pathway. This pathway is used when a manufacturer demonstrates that their device is substantially equivalent to a legally marketed device that is not subject to premarket approval. The instruments are classified as Class II devices under FDA regulations, with a product code of KNF.
What is the intended medical specialty for these laparoscopic instruments?
These instruments are intended for use in the medical specialty of obstetrics and gynecology. Their design and functionality are tailored to support procedures within this field, such as minimally invasive surgeries requiring precise tissue handling and coagulation.
Are there any specific storage requirements for these instruments?
While the provided data does not specify detailed storage instructions, as reusable medical devices, the Nezhat-Dorsey Laparoscopic Hand Instruments should be stored in a clean, dry environment to prevent contamination. After use, they must undergo proper cleaning and sterilization before storage to maintain their sterility and functionality for subsequent procedures.