Clip, Tantalum, Ophthalmic
An Ophthalmic Tantalum Clip is a small surgically implanted metallic clip made from tantalum used in ophthalmic surgery, typically as a radiopaque marker applied to the sclera to mark anatomical locations or to assist in radiotherapy planning for intraocular tumors. This device is FDA Class 2 (moderate risk), subject to general controls and special controls. It carries product code HQW and is regulated under 21 CFR 886.3100, within the Ophthalmic medical specialty. It is classified as an implant.
Research product code HQW in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HQW
- Device Class
- FDA class 2
- Regulation Number
- 886.3100
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K897119 | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP | Apr 12, 1990 | Substantially Equivalent | Grieshaber & Co. |
| K901275 | RETINAL TAAK | Mar 23, 1990 | Substantially Equivalent | Alcon Surgical, Inc. |
| K840207 | DOUBLE & SINGLE TANTALUM CLIPS | Mar 29, 1984 | Substantially Equivalent | Storz Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.