510(k) Report

FDA applicant

Aygun Surgical Instruments Co., Inc.

Kutlukent, TR1 decision2023–20230 recalls

FDA records 1 decision for Aygun Surgical Instruments Co., Inc. (Kutlukent, TR) in 2023: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). 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 hospital panel, where it files most

How often FDA has decided Aygun Surgical Instruments Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Aygun Surgical Instruments Co., Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aygun Surgical Instruments Co., Inc.’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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Which product codes does it file in?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

What has FDA decided for it lately?

  • K233222Aygün Sterilization Container SystemsAygun Surgical Instruments Co., Inc. · 2023

The one decision as Aygun Surgical Instruments Co., Inc. →