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FDA 510(k)

OVARIAN ASPIRATION/IRRIGATION NEEDLE

K-Number: K910579 · 1991-02-28

ApplicantMarlo Surgical Technology
Decision Date1991-02-28
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OVARIAN ASPIRATION/IRRIGATION NEEDLE 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 1991-02-28 under 510(k) number K910579. 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 OVARIAN ASPIRATION/IRRIGATION NEEDLE?

OVARIAN ASPIRATION/IRRIGATION NEEDLE is a medical device that received FDA 510(k) clearance on 1991-02-28. The listed applicant is Marlo Surgical Technology. The 510(k) number is K910579.

When did OVARIAN ASPIRATION/IRRIGATION NEEDLE receive FDA 510(k) clearance?

OVARIAN ASPIRATION/IRRIGATION NEEDLE received FDA 510(k) clearance on 1991-02-28, under 510(k) number K910579.

Who is the listed applicant for OVARIAN ASPIRATION/IRRIGATION NEEDLE?

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 OVARIAN ASPIRATION/IRRIGATION NEEDLE?

The FDA product code for OVARIAN ASPIRATION/IRRIGATION NEEDLE 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 ME1816NSTK924611IRRIGATION PUMP AND TUBING SETK932634NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURESK932832PRIMUS INSULATED FORCEPSK920611MARLOW LAPAROSCOPIC GRASPING FORCEP

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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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