Conform Sheeting, Model Igel
by Implantech Associates, Inc.
510(k) K012419
Conform Sheeting, Model Igel is a medical device (FDA Class I; FDA product code MDA, Elastomer, Silicone, For Scar Management) made by Implantech Associates, Inc., cleared under FDA 510(k) K012419 on 24 Oct 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012419 | Date24 Oct 2001 | StatusActive |
Official records
- FDA 510(k) database K012419
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MDA
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4025
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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- SKIN NEUVEAU SCAR TREATMENT by Puritas Health Care, Inc.
- DURASIL by The S. F. Group, Inc.
- AVOGEL by Avocet Polymer Technologies, Inc.
- NOVAGEL SILICONE GEL SHEETING by Brennen Medical, LLC
- SCAR HEAL by Specialty Systems, Inc.
- EVANESCE SCAR MANAGEMENT SYSTEM by Medical Scientific, Inc.