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FDA 510(k)

IRRI-FLO IRRIGATION DELIVERY SYSTEM

K-Number: K891339 · 1989-06-02

ApplicantSurgitek
Decision Date1989-06-02
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRI-FLO IRRIGATION DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1989-06-02 under 510(k) number K891339. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRI-FLO IRRIGATION DELIVERY SYSTEM?

IRRI-FLO IRRIGATION DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-02. The listed applicant is Surgitek. The 510(k) number is K891339.

When did IRRI-FLO IRRIGATION DELIVERY SYSTEM receive FDA 510(k) clearance?

IRRI-FLO IRRIGATION DELIVERY SYSTEM received FDA 510(k) clearance on 1989-06-02, under 510(k) number K891339.

Who is the listed applicant for IRRI-FLO IRRIGATION DELIVERY SYSTEM?

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

What is the FDA product code for IRRI-FLO IRRIGATION DELIVERY SYSTEM?

The FDA product code for IRRI-FLO IRRIGATION DELIVERY SYSTEM is OCX.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPS

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Related Devices (Code: OCX)

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.

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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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