Identifiers
- 510(k) Number
- K974653 FDA 510(k)
- FDA Product Code
- MIB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3620 FDA 510(k)
- Regulation Number
- 874.3620 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Silicone Elastomer Sheeting is a medical device classified as an Elastomer, Silicone Block. It is designed for surgical applications and meets specific quality standards for precise use in medical procedures.
The device is supplied by Specialty Surgical Products, Inc. and has FDA 510(k) clearance with product code MIB. It is a Class II device under special controls and is intended for use in ear, nose, and throat procedures. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Frequently asked questions
What is the Silicone Elastomer Sheeting used for?
The Silicone Elastomer Sheeting is designed for surgical applications, specifically for use in ear, nose, and throat procedures. It is classified as an Elastomer, Silicone Block and meets specific quality standards for precise medical use.
Is the Silicone Elastomer Sheeting single-use or reusable?
The device is not specified as single-use or reusable in the provided information. This detail should be confirmed with the manufacturer, Specialty Surgical Products, Inc., for specific usage guidelines.
What is the regulatory status of the Silicone Elastomer Sheeting?
The Silicone Elastomer Sheeting has FDA 510(k) clearance with product code MIB. It is classified as a Class II device under special controls, with clearance granted on March 13, 1998.
What are the storage conditions for the Silicone Elastomer Sheeting?
No information regarding storage conditions is provided in the device data. For proper storage guidelines, it is recommended to consult the manufacturer's instructions or contact Specialty Surgical Products, Inc. directly.
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: About Us | Specialty Surgical Products - ssp-inc.com, Products | Specialty Surgical Products - ssp-inc.com, K974653 FDA 510 (k) - SILICONE ELASTOMER SHEETING
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974653 | Class II | Active |
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Manufacturer
- Manufacturer
- Specialty Surgical Products, Inc.
Sources (1)
- FDA 510(k) K974653 24 fields · synced Sep 25, 2026