510(k) Report

FDA applicant

Marlow Surgical Technologies, Inc.

Willoughby, OH2 decisions1994–19971 recall

FDA records 2 decisions for Marlow Surgical Technologies, Inc. (Willoughby, OH) from 1994 to 1997: 2 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and MFD (Cannula, Intrauterine Insemination). 1 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 Marlow Surgical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marlow Surgical Technologies, Inc. since 2007.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Marlow Surgical Technologies, Inc. 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)1decision
  • MFDCannula, Intrauterine Insemination1decision

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.

  • K964848Wallace Artificial Insemination Catheter - 8CM/18CMMarlow Surgical Technologies, Inc. · 19973cite it
  • K944563Family of Primus Forceps: Graspers/Dissectors/Suturers/Needle DriversMarlow Surgical Technologies, Inc. · 19941cites it

What has FDA decided for it lately?

  • K964848Wallace Artificial Insemination Catheter - 8CM/18CMMarlow Surgical Technologies, Inc. · 19971 recall
  • K944563Family of Primus Forceps: Graspers/Dissectors/Suturers/Needle DriversMarlow Surgical Technologies, Inc. · 1994

All 2 as Marlow Surgical Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K964848Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units)…Feb 28, 2020Class III