Grasper-Retractor Device
510(k) K933895
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933895 | Date29 Dec 1993 | 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- Withdrawn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
- Full name
- Phx Technologies Corp., Grasper-Retractor Device
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Grasper-Retractor Device is a medical device used in gastroenterology and urology procedures. It is designed to grasp and retract tissues or objects during surgical operations.
The device is supplied as a single unit and is intended for use in a clinical setting. It has been assigned the product code GCJ and has received FDA 510K clearance, with the clearance number K933895. The device is manufactured by Phx Technologies Corp. and is available for use in the US.
Other devices from Phx Technologies Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Grasper-Retractor Device used for?
The Grasper-Retractor Device is used to grasp and retract tissues or objects during gastroenterology and urology surgical operations, facilitating procedures in a clinical setting.
Is the Grasper-Retractor Device supplied sterile?
The description does not explicitly state that the device is supplied sterile, so it is recommended to follow proper sterilization procedures before use.
Is the Grasper-Retractor Device intended for single or multiple uses?
The device is supplied as a single unit, but its intended use as single-use or reusable is not specified, so it is recommended to follow the manufacturer's guidelines.