Hook, Ophthalmic
An Ophthalmic Hook is a manual surgical instrument used in eye procedures to manipulate, retract, or position structures such as the iris, muscles, lens, or vitreous during various intraocular or extraocular surgical operations. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket submission. It carries product code HNQ and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HNQ
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K030471 | OPHTEC ENCLAVATION NEEDLE | Apr 17, 2003 | Substantially Equivalent | Ophtec, USA |
| K022842 | STEPHENS DISPOSABLE HOOKS | Nov 01, 2002 | Substantially Equivalent | Stephens Instruments |
| K874991 | PRISMA DISPOSABLE IRRIGATING IRIS HOOK | Apr 13, 1988 | Substantially Equivalent | Advanced Surgical Products, Inc. |
| K870440 | LOOK LENS LOOPS | Feb 20, 1987 | Substantially Equivalent | Look, Inc. |
| K864292 | DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY | Dec 29, 1986 | Substantially Equivalent | Eye-Ko, Inc. |
| K863988 | THORTON TITANIUM HOOK ANGLED RIGHT | Oct 31, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
| K801469 | BONN MICRO IRIS HOOK (NON-STERILE) #7613 | Jul 28, 1980 | Substantially Equivalent | Edward Weck, Inc. |
| K791985 | HOOKS #'S 7600,7602,7603,7616 | Oct 04, 1979 | Substantially Equivalent | Edward Weck, Inc. |
| K770103 | HOOK, IRIS, SHEPARD U-SHAPED | Jan 25, 1977 | Substantially Equivalent | Edward Weck, Inc. |
| K770098 | HOOK, IRIS, HERSHMAN | Jan 24, 1977 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 187 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 187 registration numbers. Click on an entry to view related FDA registrations.