HQW · Clip, Tantalum, Ophthalmic
Ophthalmic · 21 CFR 886.3100 · Class 2
Overview
| Product Code | HQW |
|---|---|
| Device Name | Clip, Tantalum, Ophthalmic |
| Regulation | 21 CFR 886.3100 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K897119 | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP | Grieshaber & Co. | Apr 12, 1990 | SESE |
| K901275 | RETINAL TAAK | Alcon Surgical, Inc. | Mar 23, 1990 | SESE |
| K840207 | DOUBLE & SINGLE TANTALUM CLIPS | Storz Instrument Co. | Mar 29, 1984 | SESE |
Top Applicants
- Alcon Surgical, Inc. — 1 clearance
- Grieshaber & Co. — 1 clearance
- Storz Instrument Co. — 1 clearance
