FDA applicant

Komet Medical, Div. of Brasseler USA I, L.P.

Savannah, GA1 decision1988–19880 recalls

FDA records 1 decision for Komet Medical, Div. of Brasseler USA I, L.P. (Savannah, GA) in 1988: 1 510(k) clearance. All are in product code GFF (Bur, Surgical, General & Plastic Surgery). 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 Komet Medical, Div. of Brasseler USA I, L.P.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Komet Medical, Div. of Brasseler USA I, L.P. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Komet Medical, Div. of Brasseler USA I, L.P. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Komet Medical, Div. of Brasseler USA…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Komet”

FDA records each applicant name separately; these may or may not be the same firm.

Komet Medical 3

Komet Medical, Div. of Brasseler USA I, L.P.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Komet”