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FDA 510(k)

FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS

K-Number: K944563 · 1994-12-27

ApplicantMarlow Surgical Technologies, Inc.
Decision Date1994-12-27
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS is the device name listed in this FDA 510(k) record. The listed applicant is Marlow Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1994-12-27 under 510(k) number K944563. 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 FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS?

FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Marlow Surgical Technologies, Inc.. The 510(k) number is K944563.

When did FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS receive FDA 510(k) clearance?

FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS received FDA 510(k) clearance on 1994-12-27, under 510(k) number K944563.

Who is the listed applicant for FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS?

The FDA 510(k) record lists Marlow Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS?

The FDA product code for FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS is HET.

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Other records listing Marlow Surgical Technologies, Inc. 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.

K964848WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM

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Official Source

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