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FDA 510(k)

IRRIGATION PUMP AND TUBING SET

K-Number: K924611 · 1994-06-30

ApplicantMarlo Surgical Technology
Decision Date1994-06-30
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IRRIGATION PUMP AND TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Marlo Surgical Technology. It received FDA 510(k) clearance on 1994-06-30 under 510(k) number K924611. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION PUMP AND TUBING SET?

IRRIGATION PUMP AND TUBING SET is a medical device that received FDA 510(k) clearance on 1994-06-30. The listed applicant is Marlo Surgical Technology. The 510(k) number is K924611.

When did IRRIGATION PUMP AND TUBING SET receive FDA 510(k) clearance?

IRRIGATION PUMP AND TUBING SET received FDA 510(k) clearance on 1994-06-30, under 510(k) number K924611.

Who is the listed applicant for IRRIGATION PUMP AND TUBING SET?

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

What is the FDA product code for IRRIGATION PUMP AND TUBING SET?

The FDA product code for IRRIGATION PUMP AND TUBING SET is HET.

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Other records listing Marlo Surgical Technology 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.

K960810BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MMK962273MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NSTK932832PRIMUS INSULATED FORCEPSK932634NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURESK920611MARLOW LAPAROSCOPIC GRASPING FORCEPK914153OTT INSUFFLATOR FILTER PLUS/TUBING SET

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Related Devices (Code: HET)

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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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