Ophthalmic Surgical Instruments
FDA 510(k) K864183 · Techno Ophthalmics Intl.
510(k) numberK864183
Submission
- Device name
- Ophthalmic Surgical Instruments
- Applicant
- Techno Ophthalmics Intl.
Irvine, CA, US - Received
- October 27, 1986
- Decision date
- November 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNR – Forceps, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022835 | Stephens Disposable ForcepsHNR · Traditional | Stephens Instruments | 11/01/2002SE |
| K895434 | Alcon Folding ForcepsHNR · Traditional | Alcon Laboratories | 12/04/1989SE |
| K891487 | Soft Lens Folding BlockHNR · Traditional | Western Medical Products, Inc. | 08/15/1989SE |
| K893199 | Phaco-Injector(Tm) Intraocular Lens Implant InstrHNR · Traditional | Allergan Medical Optics | 06/16/1989SE |
| K885230 | Mcdonald Folding ForcepsHNR · Traditional | Alcon Laboratories | 05/17/1989SE |
| K881049 | Bradbury Intraocular Retinal Kit Cat #200HNR · Traditional | Microline Pentax, Inc. | 09/12/1988SE |
| K883197 | Iol Implantation ForcepsHNR · Traditional | D & D Surgical | 08/22/1988SE |
| K880274 | Advanced Surgical Products Scleral Plug ForcepsHNR · Traditional | Advanced Surgical Products, Inc. | 02/05/1988SE |
| K864266 | Ophthalmic Knife & ForcepsHNR · Traditional | Western Medical Products, Inc. | 11/28/1986SE |
| K864071 | Faulkner ForcepsHNR · Traditional | Staar Surgical Co. | 11/13/1986SE |
Questions and answers
When was Ophthalmic Surgical Instruments cleared by the FDA?
Ophthalmic Surgical Instruments (K864183) received a 510(k) decision of Substantially Equivalent on November 28, 1986, 32 days after the submission was received.
What is the product code of K864183?
The FDA product code is HNR – Forceps, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.