Espi Non-Insulated Double-Action Grasper #8204
by Dixon Medical, Inc. 510(k)
Active
510(k) K903601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903601 | Date12 Sep 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HET
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1720
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Espi Non-Insulated Double-Action Grasper #8204 is a laparoscopic instrument used in obstetrics and gynecology. It is a type of grasper, which is a device used to grasp or hold tissue or objects during surgical procedures.
The Espi Non-Insulated Double-Action Grasper #8204 is supplied with a product code of HET and has a regulation number of 884.1720. It has been cleared by the FDA with a traditional 510(k) clearance, K903601, and is classified as a class 2 device. The device is substantially equivalent to other devices on the market and is intended for use in laparoscopic procedures in the field of obstetrics and gynecology.
Other devices from Dixon Medical, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the Espi Non-Insulated Double-Action Grasper #8204 used for?
The Espi Non-Insulated Double-Action Grasper #8204 is used in laparoscopic procedures in the field of obstetrics and gynecology to grasp or hold tissue or objects during surgical procedures.
Is the Espi Non-Insulated Double-Action Grasper #8204 a single-use or reusable device?
The device data does not specify whether the Espi Non-Insulated Double-Action Grasper #8204 is single-use or reusable, it is recommended to consult the manufacturer's instructions for use.
What is the product code for the Espi Non-Insulated Double-Action Grasper #8204?
The product code for the Espi Non-Insulated Double-Action Grasper #8204 is HET.
What is the regulation number for the Espi Non-Insulated Double-Action Grasper #8204?
The regulation number for the Espi Non-Insulated Double-Action Grasper #8204 is 884.1720.