Identifiers
- 510(k) Number
- K923725 FDA 510(k)
- FDA Product Code
- HQC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4670 FDA 510(k)
- Regulation Number
- 886.4670 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ophthalmic Pharco Needle is a Class II medical device used in ophthalmic procedures. It is designed for use in phacoemulsification, a surgical technique for removing cataracts.
The device is supplied by Synergetics, Inc. and received FDA 510(k) clearance on March 18, 1993. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Ophthalmic Pharco Needle used for?
The Ophthalmic Pharco Needle is a Class II medical device specifically designed for use in phacoemulsification, a surgical technique for removing cataracts during ophthalmic procedures.
Is the Ophthalmic Pharco Needle single-use or reusable?
The device data does not specify whether the Ophthalmic Pharco Needle is intended for single-use or reusable applications. This information should be obtained directly from the manufacturer or product documentation.
What regulatory authorization does the Ophthalmic Pharco Needle have?
The Ophthalmic Pharco Needle received FDA 510(k) clearance on March 18, 1993, with the K number K923725. It is classified as a Class II medical device and was determined to be substantially equivalent to predicate devices.
What are the specifications of the Ophthalmic Pharco Needle?
The Ophthalmic Pharco Needle is manufactured by Synergetics, Inc. and has a product code HQC. It is designed for ophthalmic procedures, specifically phacoemulsification for cataract removal. No specific measurements or sizes are provided in the device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OPHTHALMIC PHARCO NEEDLE (K923725) — FDA 510 (k) | Innolitics, Ophthalmic Pharco Needle 510 (k) FDA Premarket Notification K923725 ..., Synergetics, Inc. · DeviceClearance, Synergetics - Bausch Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923725 | Class II | Active |
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Manufacturer
- Manufacturer
- Synergetics, Inc.
Sources (1)
- FDA 510(k) K923725 24 fields · synced Sep 22, 2026