Surgin Genisis Phacoemulsifier
FDA 510(k) K954241 · Surgeon Surgical Instrumentation, Inc.
510(k) numberK954241
Submission
- Device name
- Surgin Genisis Phacoemulsifier
- Applicant
- Surgeon Surgical Instrumentation, Inc.
Temple City, CA, US - Received
- September 11, 1995
- Decision date
- December 1, 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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| K890447 | Hemorrhage OccludorGDW · Traditional | 02/23/1989SE |
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| K881232 | Surgin Eye ShieldHOY · Traditional | 04/13/1988SE |
| K861203 | Multi-SpikeKYG · Traditional | 04/28/1986SE |
| K852229 | Sterile Eye Packs or Trays · Traditional | 06/07/1985SE |
| K830859 | I/A KitGBX · Traditional | 05/02/1983SE |
Questions and answers
When was Surgin Genisis Phacoemulsifier cleared by the FDA?
Surgin Genisis Phacoemulsifier (K954241) received a 510(k) decision of Substantially Equivalent on December 1, 1995, 81 days after the submission was received.
What is the product code of K954241?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.