510(k) Report

FDA applicant

Marlo Surgical Technology

Willoughby, OH28 decisions1985–19960 recalls

FDA records 28 decisions for Marlo Surgical Technology (Willoughby, OH) from 1985 to 1996: 28 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and GCJ (Laparoscope, General & Plastic Surgery). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Marlo Surgical Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marlo Surgical Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Marlo Surgical Technology by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HETLaparoscope, Gynecologic (And Accessories)10decisions
  • GCJLaparoscope, General & Plastic Surgery5decisions
  • MFDCannula, Intrauterine Insemination2decisions
  • KYPSnake Bite Suction Kit1decision
  • KDCInstrument, Surgical, Disposable1decision
  • HIFInsufflator, Laparoscopic1decision

Also: GCM (1), HTD (1), GSJ (1), HIS (1), GEX (1), HDC (1).

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K910577Edwards-Wallace Bourne Hall CatheterMarlo Surgical Technology · 19912cite it
  • K903078Hasson Stabilizing Access CannulaMarlo Surgical Technology · 19901cites it
  • K932832Primus Insulated ForcepsMarlo Surgical Technology · 19941cites it

What has FDA decided for it lately?

  • K960810Balloon Cannula 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MMMarlo Surgical Technology · 1996
  • K962273Malleable Stylet 18 CM ME1816ST, 23 CM ME1816NSTMarlo Surgical Technology · 1996
  • K924611Irrigation Pump and Tubing SetMarlo Surgical Technology · 1994
  • K932634NU-Tip (TM) Forceps:Graspers/Dissectors/SuturesMarlo Surgical Technology · 1994
  • K932832Primus Insulated ForcepsMarlo Surgical Technology · 1994
  • K920611Marlow Laparoscopic Grasping ForcepMarlo Surgical Technology · 1993
  • K914153Ott Insufflator Filter Plus/Tubing SetMarlo Surgical Technology · 1992
  • K914869Marlow Laparoscopic ScissorsMarlo Surgical Technology · 1992

All 28 as Marlo Surgical Technology →