Identity
- Trade Name
- COHERA MEDICAL TISSUGLU FDA PMA
- Generic Name
- Tissue adhesive for internal use FDA PMA
Identifiers
- PMA Number
- P130023 FDA PMA
- FDA Product Code
- PJK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 878.4010 FDA PMA
- Regulation Number
- 878.4010 FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The TissueGlu Surgical Adhesive is a tissue adhesive for internal use, designed to approximate tissue layers where subcutaneous dead space exists between tissue planes. It is classified under the nomenclature for tissue adhesives intended for internal surgical applications, specifically within general and plastic surgery procedures.
This adhesive is supplied as a sterile, single-use product and is indicated for use in abdominoplasty to close tissue planes where dead space may form. It is regulated under FDA PMA approval (P130023) and falls under device class III (regulation number 878.4010). Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What is the TissueGlu Surgical Adhesive used for?
The TissueGlu Surgical Adhesive is designed to approximate tissue layers where subcutaneous dead space exists between tissue planes, specifically indicated for use in abdominoplasty procedures.
How is the TissueGlu Surgical Adhesive supplied?
The adhesive is supplied as a sterile, single-use product that must be handled according to sterile medical device protocols.
What are the storage requirements for TissueGlu Surgical Adhesive?
Storage and handling must comply with sterile medical device protocols to maintain the product's integrity and sterility.
Is the TissueGlu Surgical Adhesive reusable?
No, the TissueGlu Surgical Adhesive is supplied as a single-use product and should not be reused for any patient or procedure.
What is the regulatory classification of TissueGlu Surgical Adhesive?
The TissueGlu Surgical Adhesive is classified under device class III with regulation number 878.4010 and received FDA PMA approval (P130023).
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P130023 | Class III | Active |
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Manufacturer
- Manufacturer
- Cohera Medical, Inc.
Sources (1)
- FDA PMA P130023 24 fields · synced Oct 6, 2026