Soft Silicone Elastomer Sponge Explant
by Medical Instrument Research Assoc., Inc.
510(k) K780987
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780987 | Date28 Sep 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4790
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is classified as an ophthalmic sponge, specifically a soft silicone elastomer sponge designed for explantation procedures. It is intended for use in surgical settings where removal of ocular or periocular tissue is required, providing a compliant, non-adherent surface to facilitate gentle extraction without damaging surrounding structures. The material properties of the silicone elastomer allow for flexibility and elasticity, ensuring safe handling during delicate procedures.
The Soft Silicone Elastomer Sponge Explant is supplied as a single-use, sterile device for surgical applications in ophthalmology. It is classified under FDA device class 2 and holds a 510(k) clearance (K780987) as substantially equivalent to a predicate device. The product is intended for use in controlled sterile environments and must be handled according to standard surgical protocols. No additional regulatory approvals beyond the 510(k) clearance are referenced in the data.
Other devices from Medical Instrument Research Assoc., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Soft Silicone Elastomer Sponge Explant used for?
The Soft Silicone Elastomer Sponge Explant is specifically designed for surgical explantation procedures in ophthalmology. It provides a compliant, non-adherent surface to facilitate the removal of ocular or periocular tissue without damaging surrounding structures. Its flexible and elastic silicone elastomer material ensures safe handling during delicate surgeries.
Is the Soft Silicone Elastomer Sponge Explant single-use or reusable?
This device is intended for single-use only. It is supplied sterile and must remain in a sterile condition until use, adhering to standard surgical protocols to prevent contamination and ensure patient safety.
How is the Soft Silicone Elastomer Sponge Explant supplied?
The sponge is supplied as a sterile, single-use device, packaged for surgical environments. It is intended to be used in controlled sterile conditions and should be handled according to standard aseptic techniques to maintain sterility.
What are the key material properties of the Soft Silicone Elastomer Sponge Explant?
The sponge is made from a soft silicone elastomer, which provides flexibility and elasticity. These properties allow for gentle manipulation during explantation, reducing the risk of trauma to delicate ocular or periocular tissues while ensuring effective removal.
What regulatory clearance does the Soft Silicone Elastomer Sponge Explant hold?
The device holds an FDA 510(k) clearance (K780987) and is classified under FDA device class 2. It is deemed substantially equivalent to a predicate device and is intended for use in controlled sterile environments as part of ophthalmic surgical procedures.