Storz I/A Handpieces
FDA 510(k) K951463 · Storz Instrument Co.
510(k) numberK951463
Submission
- Device name
- Storz I/A Handpieces
- Applicant
- Storz Instrument Co.
St. Louis, MO, US - Received
- March 30, 1995
- Decision date
- October 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980100 | Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackMSR · Traditional | 06/01/1998SE |
| K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy SystemHQE · Traditional | 03/23/1998SE |
| 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 I/A Handpieces cleared by the FDA?
Storz I/A Handpieces (K951463) received a 510(k) decision of Substantially Equivalent on October 27, 1995, 211 days after the submission was received.
What is the product code of K951463?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.