Spatula, Ophthalmic
The Ophthalmic Spatula is a thin, flat, blunt-ended instrument used in ocular surgery to manipulate, separate, or position delicate ocular tissues such as the iris, capsule, or vitreous during procedures including cataract surgery and corneal repair. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without a premarket notification submission. The product code is HND, regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HND
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863990 | THORNTON TITANIUM SILVER SPATULA | Oct 31, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
| K810937 | ANIS IRRIGATING SPATULA | May 15, 1981 | Substantially Equivalent | American V. Mueller |
| K801609 | MADDOX LENS SPATULA CAT. #7245 | Aug 13, 1980 | Substantially Equivalent | Edward Weck, Inc. |
| K801608 | MCCULLEY CONTINUOUS SUTURE TIGHTNER | Aug 12, 1980 | Substantially Equivalent | Edward Weck, Inc. |
| K791983 | SPATULA'S #'S 7618,7248,7240,7242,5108 | Oct 04, 1979 | Substantially Equivalent | Edward Weck, Inc. |
| K761253 | CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM | Dec 16, 1976 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 160 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 160 registration numbers. Click on an entry to view related FDA registrations.