Product code HNQ
- Device name
- Hook, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030471 | OPHTEC ENCLAVATION NEEDLE | Ophtec, USA | 2003-04-17 |
| K022842 | STEPHENS DISPOSABLE HOOKS | Stephens Instruments | 2002-11-01 |
| K874991 | PRISMA DISPOSABLE IRRIGATING IRIS HOOK | Advanced Surgical Products, Inc. | 1988-04-13 |
| K870440 | LOOK LENS LOOPS | Look, Inc. | 1987-02-20 |
| K864292 | DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY | Eye-Ko, Inc. | 1986-12-29 |
| K863988 | THORTON TITANIUM HOOK ANGLED RIGHT | Keeler Instruments, Inc. | 1986-10-31 |
| K801469 | BONN MICRO IRIS HOOK (NON-STERILE) #7613 | Edward Weck, Inc. | 1980-07-28 |
| K791985 | HOOKS #'S 7600,7602,7603,7616 | Edward Weck, Inc. | 1979-10-04 |
| K770103 | HOOK, IRIS, SHEPARD U-SHAPED | Edward Weck, Inc. | 1977-01-25 |
| K770098 | HOOK, IRIS, HERSHMAN | Edward Weck, Inc. | 1977-01-24 |
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| G2231196710 | Medetz Surgical Instruments | Medetz Surgical Instruments LLC | 2023-09-19 |
| G2231196700 | Medetz Surgical Instruments | Medetz Surgical Instruments LLC | 2023-01-12 |
| 10190660199392 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660199385 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660199378 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660199347 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660199354 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660199361 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-07 |
| 10190660199415 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
| 10190660199330 | Ambler Surgical | AMBLER SURGICAL CORP. | 2021-01-04 |
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