# Absorbable Lung Biopsy Plug
> **Product code: OMT** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4755
## Classification
- **FDA Product Code:** OMT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4755
- **Review panel:** AN
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 10
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OMT)
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