Definition: A Carbon Dioxide Gas Controlled Tissue Expander Is Intended For Tissue Expansion.
| Device Type ID | 5875 |
| Device Name | Carbon Dioxide Gas Controlled Tissue Expander |
| Physical State | It Includes An Inflatable Elastomer Shell With An Implanted Canister Containing Compressed Carbon Dioxide. It Includes A Remote Controller That Communicates With The Implanted Tissue Expander To Release Carbon Dioxide From The Implanted Canister Into |
| Technical Method | A Carbon Dioxide Gas Controlled Tissue Expander Is Made Of An Inflatable Elastomer Shell And Is Filled With Carbon Dioxide Gas. It Utilizes A Remote Controller To Administer Doses Of Carbon Dioxide Gas From An Implanted Canister Inside The Tissue Exp |
| Target Area | Breasts, Soft Tissue |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5875 |
| Device | Carbon Dioxide Gas Controlled Tissue Expander |
| Product Code | PQN |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 878.3510 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AIRXPANDERS, INC | ||
GRANTED | 1 | |
AIRXPANDERS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Expander | 3 |
Free Or Unrestricted Flow | 1 |
Inaccurate Delivery | 1 |
Gas Leak | 1 |
| Total Device Problems | 6 |