Bonn Micro Iris Hook (Non-Sterile) #7613
FDA 510(k) K801469 · Edward Weck, Inc.
510(k) numberK801469
Submission
- Device name
- Bonn Micro Iris Hook (Non-Sterile) #7613
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- June 24, 1980
- Decision date
- July 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K022842 | Stephens Disposable HooksHNQ · Traditional | Stephens Instruments | 11/01/2002SE |
| 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 |
| 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 |
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|---|---|---|
| K915378 | Weck TrocarHET · Traditional | 06/29/1992SE |
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| K911915 | Hemoclip IIFZP · Traditional | 01/09/1992SE |
| K914470 | Pneumo-Seal(Tm)GCJ · Traditional | 11/29/1991SE |
| K911272 | Endoscopic Needlholder Cat. Number 114705FHG · Traditional | 07/02/1991SE |
| K902108 | Hem-O-Lok(Tm)FZP · Traditional | 08/06/1990SE |
| K902232 | Weck Electrosurgical Generator #174200GEI · Traditional | 08/02/1990SE |
| K897045 | Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional | 02/15/1990SE |
| K871110 | Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional | 08/27/1987SE |
| K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional | 07/02/1985SE |
Questions and answers
When was Bonn Micro Iris Hook (Non-Sterile) #7613 cleared by the FDA?
Bonn Micro Iris Hook (Non-Sterile) #7613 (K801469) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 34 days after the submission was received.
What is the product code of K801469?
The FDA product code is HNQ – Hook, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.