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Novoglan

PLATIGO SOLUTIONS PTY LIMITED · Model NFTE20221 · UDI-DI 00860009967205

510(k) clearances

Adverse events

Recalls

Facilities

Description

A collection of devices intended to be operated by a patient at home to stretch the foreskin of the penis to treat phimosis (tightening of the foreskin) or to preferentially develop a looser foreskin. It consists of a balloon assembly, an inflator, cotton buds, insertion rods, and cleansing swabs. The inflatable balloon is inserted through the natural opening of the foreskin and positioned between the glans penis and the foreskin and inflated. This procedure is typically performed daily for a period (e.g., 14 days) to gradually stretch the foreskin. This is a single-patient device reapplied to the patient over a short term (single-use) before being discarded.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.