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Aygun Surgical Instruments Co., Inc.

FDA Regulatory Profile

Aygun Surgical Instruments Co., Inc. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Aygun Surgical Instruments Co., Inc." and its spelling variant "Aygun Surgical Instruments Co".

Latest inspection: Apr 18, 2013 · OAI
Latest 510(k): Dec 12, 2023

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

1 inspection on Apr 18, 2013.

Date	Site	Product	Classification	FEI
Apr 18, 2013	Kutlukent, Turkey	Devices	Official Action Indicated (OAI)	3006113180

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Aygun Surgical Instruments Co., Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 27, 2013.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3006113180	Kutlukent, Turkey	1	Apr 18, 2013

Recent 510(k) clearances

1 510(k) clearance on Dec 12, 2023.

K-Number	Device	Date
K233222	Aygün Sterilization Container Systems	Dec 12, 2023

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