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FDA 510(k)

IRRIGATION PUMPS AND TUBING AND SUCTION TUBING

K-Number: K921457 · 1993-05-13

ApplicantAmerican Surgical Instruments Corp.
Decision Date1993-05-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRIGATION PUMPS AND TUBING AND SUCTION TUBING is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Instruments Corp.. It received FDA 510(k) clearance on 1993-05-13 under 510(k) number K921457. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION PUMPS AND TUBING AND SUCTION TUBING?

IRRIGATION PUMPS AND TUBING AND SUCTION TUBING is a medical device that received FDA 510(k) clearance on 1993-05-13. The listed applicant is American Surgical Instruments Corp.. The 510(k) number is K921457.

When did IRRIGATION PUMPS AND TUBING AND SUCTION TUBING receive FDA 510(k) clearance?

IRRIGATION PUMPS AND TUBING AND SUCTION TUBING received FDA 510(k) clearance on 1993-05-13, under 510(k) number K921457.

Who is the listed applicant for IRRIGATION PUMPS AND TUBING AND SUCTION TUBING?

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

What is the FDA product code for IRRIGATION PUMPS AND TUBING AND SUCTION TUBING?

The FDA product code for IRRIGATION PUMPS AND TUBING AND SUCTION TUBING is GCJ.

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Other records listing American Surgical Instruments Corp. 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.

K921716DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEMK913944NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIESK913999NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBEK911274UNIPOLAR COAGULATOR PROBE SYSTEMK896118NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

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

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