Manual Ophthalmic Surgical Instruments
FDA 510(k) K861141 · CooperVision, Inc.
510(k) numberK861141
Submission
- Device name
- Manual Ophthalmic Surgical Instruments
- Applicant
- CooperVision, Inc.
Bellevue, WA, US - Received
- March 26, 1986
- Decision date
- April 24, 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 |
| K864183 | Ophthalmic Surgical InstrumentsHNR · Traditional | Techno Ophthalmics Intl. | 11/28/1986SE |
More from Techno Ophthalmics Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…LPL · Special | 01/25/2024SE |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special | 02/04/2022SE |
| K213164 | Avaira VitalityLPL · Special | 10/26/2021SE |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…LPL · Special | 10/20/2020SE |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
Questions and answers
When was Manual Ophthalmic Surgical Instruments cleared by the FDA?
Manual Ophthalmic Surgical Instruments (K861141) received a 510(k) decision of Substantially Equivalent on April 24, 1986, 29 days after the submission was received.
What is the product code of K861141?
The FDA product code is HNR – Forceps, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.