Identifiers
- 510(k) Number
- K950241 FDA 510(k)
- FDA Product Code
- HOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4790 FDA 510(k)
- Regulation Number
- 886.4790 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ophthalmic Sponges are classified as ophthalmic sponges, designed for use in eye care procedures. These devices are intended to absorb moisture, irrigate, or cleanse ocular surfaces during surgical or clinical interventions, ensuring proper hygiene and preparation of the eye.
Supplied as single-use, non-sterile devices, these sponges are intended for use in controlled clinical settings where sterility can be achieved through standard surgical protocols. They are regulated under FDA 510(k) clearance (K950241) and fall under Class II medical devices, adhering to regulatory standards for ophthalmic applications. Multiple sizes and variants are available, as indicated by the associated registration numbers.
Frequently asked questions
Are these ophthalmic sponges sterile when packaged, and if not, how should they be prepared for use in surgery?
No, these ophthalmic sponges are supplied as non-sterile devices. Since they are intended for use in controlled clinical settings, sterility must be achieved through standard surgical protocols, such as autoclaving or chemical sterilization, prior to use in procedures.
What sizes or variants of these ophthalmic sponges are available, and how can I identify them?
Multiple sizes and variants of these ophthalmic sponges are available, each associated with a unique registration number (e.g., 3019924, 1000208624, etc.). These numbers are listed in the regulatory records and can help distinguish between different models or configurations. The manufacturer, Oasis Medical, Inc., likely provides documentation specifying which size corresponds to each registration number.
Are these sponges intended for single-use only, and if so, what happens if they are reused?
Yes, these ophthalmic sponges are explicitly labeled as single-use devices. Reusing them could compromise patient safety by introducing contamination or compromising their absorbency and hygiene properties, which are critical for ocular procedures.
How should these sponges be stored, and are there any special handling instructions?
Since these sponges are non-sterile, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging should remain intact until sterilization is performed before use. The manufacturer’s instructions (not provided here) would detail any additional storage precautions, but standard medical device storage guidelines apply.
What is the regulatory pathway for these ophthalmic sponges, and how can I verify their compliance?
These ophthalmic sponges are regulated under the FDA 510(k) clearance process (K950241) and are classified as Class II medical devices. They were determined to be substantially equivalent to a predicate device and fall under the Ophthalmic advisory committee (OP). Compliance can be verified through the FDA’s OpenFDA database or by checking the listed registration numbers and product codes (e.g., HOZ).
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: OASIS® Medical - Nourishing and sustaining the eye-care community - for ..., OPHTHALMIC SPONGES (K950241) — FDA 510 (k) | Innolitics, Catalogs - OASIS® Medical, Ophthalmic Sponges 510 (k) FDA Premarket Notification K950241 OASIS ..., Ophthalmic Sponges - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950241 | Class II | Active |
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Manufacturer
- Manufacturer
- OASIS Medical, Inc.
Sources (1)
- FDA 510(k) K950241 24 fields · synced Sep 19, 2026