Storz/Mazzacco Lens Forcep
FDA 510(k) K860915 · Storz Instrument Co.
510(k) numberK860915
Submission
- Device name
- Storz/Mazzacco Lens Forcep
- Applicant
- Storz Instrument Co.
St. Louis, MO, US - Received
- March 11, 1986
- Decision date
- April 15, 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 |
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| K972664 | Storz Millennium Viscous Fluid SystemMRH · Traditional | 10/10/1997SE |
| K971439 | Storz Microflow and Storz Standard Phacoemulsification NeedlesHQC · Traditional | 06/17/1997SE |
| K964743 | Storz E8010 Ergotec/Premiere AdaptorHQE · Traditional | 02/03/1997SE |
| K960024 | Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle WrenchHQC · Traditional | 09/20/1996SE |
| K960061 | Storz D7108 Microscissors Handpiece/Storz D7106 Microscissors Drive TubeHQE · Traditional | 09/18/1996SE |
| K960003 | Storz D7116 Microvit Vitrectomy Cutter ExtensionHQC · Traditional | 08/29/1996SE |
| K962131 | Storz D4600 Air Exchange Line PackHQC · Traditional | 08/23/1996SE |
| K961874 | Storz DP5100 Anterior Collection Cassette PackHQC · Traditional | 08/06/1996SE |
Questions and answers
When was Storz/Mazzacco Lens Forcep cleared by the FDA?
Storz/Mazzacco Lens Forcep (K860915) received a 510(k) decision of Substantially Equivalent on April 15, 1986, 35 days after the submission was received.
What is the product code of K860915?
The FDA product code is HNR – Forceps, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.