GORE® ENFORM Biomaterial
FDA 510(k) clearance K222919 · decided 2022-12-19
Clearance details
- K-number
- K222919
- Device name
- GORE® ENFORM Biomaterial
- Applicant
- W. L. Gore and Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-26
- Decision date
- 2022-12-19
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- OXF
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch W. L. Gore and Associates
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Restrata Soft Tissue Reinforcement (STR) (K251224) | Acera Surgical, Inc. | 2025-06-20 |
| 3DMatrix DynaFlex (DynaFlex) (K243302) | Printbio, Inc. | 2025-05-21 |
| 3DMatrix Surgical Mesh (K232602) | Printbio, Inc. | 2024-05-23 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |
| SERI Contour (K172545) | Sofregen Medical, Inc. | 2017-09-22 |
| GORE BIO-A Tissue Reinforcement (K163217) | W. L. Gore & Associates, Inc. | 2017-02-10 |
| SERI SURGICAL SCAFFOLD (K123128) | Allergan | 2013-04-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S023) | W. L. Gore and Associates, Inc. | 2025-12-05 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00 (P200030/S022) | W. L. Gore and Associates, Inc. | 2025-08-29 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) (P200030/S021) | W. L. Gore and Associates, Inc. | 2025-06-05 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (P200030/S020) | W. L. Gore and Associates, Inc. | 2025-06-05 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S019) | W. L. Gore and Associates, Inc. | 2025-03-11 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P200030/S016) | W. L. Gore and Associates, Inc. | 2024-12-04 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S018) | W. L. Gore and Associates, Inc. | 2024-09-06 |
| Gore Excluder Conformable AAA Endoprosthesis (CEXC) (P200030/S017) | W. L. Gore and Associates, Inc. | 2024-06-21 |