510(k) Report

FDA applicant

Marina Medical Instruments, Inc.

Alpharetta, GA5 decisions2001–20050 recalls

FDA records 5 decisions for Marina Medical Instruments, Inc. (Alpharetta, GA) from 2001 to 2005: 5 510(k) clearances. Most are in product codes HHW (Pessary, Vaginal) and GDW (Staple, Implantable). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Marina Medical Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marina Medical Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Marina Medical Instruments, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Marina Medical Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HHWPessary, Vaginal1decision
  • GDWStaple, Implantable1decision
  • KGOSurgeon'S Gloves1decision
  • LKFCannula, Manipulator/Injector, Uterine1decision
  • HHKCurette, Suction, Endometrial (And Accessories)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K021876Mas with or Without SyringeMarina Medical Instruments, Inc. · 20031cites it

What has FDA decided for it lately?

  • K042534Marina Medical Finger ProtectorsMarina Medical Instruments, Inc. · 2005
  • K031463Marina Medical Silicone PessaryMarina Medical Instruments, Inc. · 2003
  • K021876Mas with or Without SyringeMarina Medical Instruments, Inc. · 2003
  • K023725Hemorrhage Occluder Pin (Hop), Model 337-247Marina Medical Instruments, Inc. · 2003
  • K010296Uterine Manipulator Injector Cannula, Model R57-450Marina Medical Instruments, Inc. · 2001

All 5 as Marina Medical Instruments, Inc. →