OMTClass II
Absorbable Lung Biopsy Plug
21 CFR 878.4755 / General, Plastic Surgery
OMT is the FDA product code for Absorbable Lung Biopsy Plug, a class II device type, regulated under 21 CFR 878.4755. FDA's definition for this code reads: "A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- OMT
- Device name
- Absorbable Lung Biopsy Plug
- FDA definition
- A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.
- Regulation
- 21 CFR 878.4755
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 1
Clearances, product code OMT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code OMT| Applicant | Clearances |
|---|---|
| Angiotech | 1 |
| Selio Medical Limited | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.