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FDA 510(k)

SUCTION IRRIGATOR

K-Number: K003443 · 2001-02-01

ApplicantApplied Medical
Decision Date2001-02-01
Product CodeFHF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUCTION IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K003443. The device is classified under product code FHF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION IRRIGATOR?

SUCTION IRRIGATOR is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is Applied Medical. The 510(k) number is K003443.

When did SUCTION IRRIGATOR receive FDA 510(k) clearance?

SUCTION IRRIGATOR received FDA 510(k) clearance on 2001-02-01, under 510(k) number K003443.

Who is the listed applicant for SUCTION IRRIGATOR?

The FDA 510(k) record lists Applied Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUCTION IRRIGATOR?

The FDA product code for SUCTION IRRIGATOR is FHF.

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Other records listing Applied Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202818Voyant Fine Fusion Device (EB230)K191866GelPOINT Mini Advanced Access PlatformK122619EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SETK070865EXPANDING VASCULAR SHEATHK002915FLEXIBLE OCCLUSION SYSTEMK915826BIO-POLAR FORCEPS

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Related Devices (Code: FHF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093479DISPOSABLE SUCTION AND IRRIGATION SYSTEMModern Medical Equipment Mfg., Ltd.K771986CATHETER, MEDIASTINAL&PERICARDIALThe Minnesota Back Brace Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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