HOC · Clip, Iris Retractor
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HOC |
|---|---|
| Device Name | Clip, Iris Retractor |
| Regulation | 21 CFR 886.4350 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871474 | PART #860070 ULTRAPAK & #860075 ULTRAPAK | Medical Technical Products | Aug 10, 1987 | SESE |
| K830871 | PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION | Phakosystems, Inc. | Jun 2, 1983 | SESE |
Top Applicants
- Phakosystems, Inc. — 1 clearance
- Medical Technical Products — 1 clearance
