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FDA PMA

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

PMA Number: P980053 · 2026-03-13

ApplicantCarbon Medical Technologies, Inc.
Decision Date2026-03-13
PMA NumberP980053
Product CodeLNM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2026-03-13. The device is classified under product code LNM. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE?

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Carbon Medical Technologies, Inc..

When did AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE receive FDA 510(k) clearance?

The clearance date for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE can be found in the official FDA records.

Who is the listed applicant for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE?

The FDA 510(k) record lists Carbon Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE?

The FDA product code for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE is LNM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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