HND · Spatula, Ophthalmic
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HND |
|---|---|
| Device Name | Spatula, Ophthalmic |
| 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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863990 | THORNTON TITANIUM SILVER SPATULA | Keeler Instruments, Inc. | Oct 31, 1986 | SESE |
| K810937 | ANIS IRRIGATING SPATULA | American V. Mueller | May 15, 1981 | SESE |
| K801609 | MADDOX LENS SPATULA CAT. #7245 | Edward Weck, Inc. | Aug 13, 1980 | SESE |
| K801608 | MCCULLEY CONTINUOUS SUTURE TIGHTNER | Edward Weck, Inc. | Aug 12, 1980 | SESE |
| K791983 | SPATULA'S #'S 7618,7248,7240,7242,5108 | Edward Weck, Inc. | Oct 4, 1979 | SESE |
| K761253 | CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM | Edward Weck, Inc. | Dec 16, 1976 | SESE |
Top Applicants
- Edward Weck, Inc. — 4 clearances
- Keeler Instruments, Inc. — 1 clearance
- American V. Mueller — 1 clearance
