Stephens Disposable Hooks
FDA 510(k) K022842 · Stephens Instruments
510(k) numberK022842
Submission
- Device name
- Stephens Disposable Hooks
- Applicant
- Stephens Instruments
Lexington, KY, US - Received
- August 27, 2002
- Decision date
- November 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HNQ – Hook, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030471 | Ophtec Enclavation NeedleHNQ · Traditional | Ophtec, USA | 04/17/2003SE |
| K874991 | Prisma Disposable Irrigating Iris HookHNQ · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K870440 | Look Lens LoopsHNQ · Traditional | Look, Inc. | 02/20/1987SE |
| K864292 | Disposal Surgical Instruments for OphthalmologyHNQ · Traditional | Eye-Ko, Inc. | 12/29/1986SE |
| K863988 | Thorton Titanium Hook Angled RightHNQ · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K801469 | Bonn Micro Iris Hook (Non-Sterile) #7613HNQ · Traditional | Edward Weck, Inc. | 07/28/1980SE |
| K791985 | Hooks #'S 7600,7602,7603,7616HNQ · Traditional | Edward Weck, Inc. | 10/04/1979SE |
| K770103 | Hook, Iris, Shepard U-ShapedHNQ · Traditional | Edward Weck, Inc. | 01/25/1977SE |
| K770098 | Hook, Iris, HershmanHNQ · Traditional | Edward Weck, Inc. | 01/24/1977SE |
More from Edward Weck, Inc.
Questions and answers
When was Stephens Disposable Hooks cleared by the FDA?
Stephens Disposable Hooks (K022842) received a 510(k) decision of Substantially Equivalent on November 1, 2002, 66 days after the submission was received.
What is the product code of K022842?
The FDA product code is HNQ – Hook, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.