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FDA 510(k)

SYRINGE, IRRIGATION, PRE-FILLED

K-Number: K772134 · 1977-11-28

ApplicantKendall Research Center
Decision Date1977-11-28
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYRINGE, IRRIGATION, PRE-FILLED is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Research Center. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772134. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRINGE, IRRIGATION, PRE-FILLED?

SYRINGE, IRRIGATION, PRE-FILLED is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Kendall Research Center. The 510(k) number is K772134.

When did SYRINGE, IRRIGATION, PRE-FILLED receive FDA 510(k) clearance?

SYRINGE, IRRIGATION, PRE-FILLED received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772134.

Who is the listed applicant for SYRINGE, IRRIGATION, PRE-FILLED?

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

What is the FDA product code for SYRINGE, IRRIGATION, PRE-FILLED?

The FDA product code for SYRINGE, IRRIGATION, PRE-FILLED is KOA.

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Other records listing Kendall Research Center as applicant

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K802225TENDER-SORB DRAIN SPONGESK781357T.E.D. SEQUENTIAL COMPRESSION SLEEVESK780408MICRONET LIGHT DRESSING SPONGEK780062CATHETER/HEMOSTATIC/GERIATRICK780120ANESTHESIA TRAY, CAUDALK772133URINE SPECIMEN COLLECTING DEVICE

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Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American Medical, Inc.

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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