FDA applicant

P.T. Saptindo Surgica

Serang-Banten, ID3 decisions1995–20030 recalls

FDA records 3 decisions for P.T. Saptindo Surgica (Serang-Banten, ID) from 1995 to 2003: 3 510(k) clearances. All are in product code KGO (Surgeon'S Gloves). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided P.T. Saptindo Surgica’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for P.T. Saptindo Surgica since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — P.T. Saptindo Surgica by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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P.T. Saptindo Surgica

Which product codes does it file in?

What has FDA decided for it lately?