Grieshaber Retinal Tack and Sutherland Tack Forcep
510(k) K897119
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK897119 | Date12 Apr 1990 | 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- Withdrawn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
- HQW
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.3100
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Grieshaber Retinal Tack and Sutherland Tack Forceps are ophthalmic surgical instruments designed for retinal fixation. These forceps are used to apply tantalum retinal tacks, which secure the retina in place during retinal detachment repair procedures. The device includes both the tacks and the forceps required to position them accurately within the eye. Tantalum tacks are biocompatible and provide mechanical stabilization to the retinal tissue.
These forceps are intended for single-use in sterile surgical settings, adhering to ophthalmic surgical standards. The device is classified under FDA Class II (HQW product code) and holds an FDA 510(k) clearance (K897119) for substantial equivalence. The forceps are supplied sterile and must be handled in accordance with aseptic techniques. No MRI safety information is specified, and the device is not reusable. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Grieshaber & Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Grieshaber Retinal Tack and Sutherland Tack Forceps used for?
This device is specifically designed for retinal detachment repair procedures. The forceps apply tantalum retinal tacks, which provide mechanical stabilization to the retina by securing it in place. The biocompatible tantalum tacks ensure the retina remains properly positioned during healing.
Are the forceps and tacks supplied sterile, and how should they be handled?
Yes, the Grieshaber Retinal Tack and Sutherland Tack Forceps are supplied sterile. They must be handled using aseptic techniques to maintain sterility, as required for surgical settings. Improper handling could compromise the device’s integrity and patient safety.
Can the Grieshaber Retinal Tack and Sutherland Tack Forceps be reused?
No, these forceps are intended for single-use only. Reuse is not recommended due to the risk of contamination and potential damage to the instrument, which could affect precision and patient outcomes during retinal surgery.
What materials are the retinal tacks made of, and why is this important?
The retinal tacks are made of tantalum, a biocompatible material. This is important because it minimizes the risk of adverse tissue reactions, ensuring the tacks integrate well with retinal tissue while providing stable fixation during the healing process.
How should the device be stored to maintain its functionality?
Storage should follow the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping the device in its original packaging, away from moisture, extreme temperatures, and direct light, until ready for use in a sterile surgical environment.