510(k) Report

FDA applicant

Microptix Int'L, LLC

East Haven, CT1 decision1999–19991 recall

FDA records 1 decision for Microptix Int'L, LLC (East Haven, CT) in 1999: 1 510(k) clearance. All are in product code HET (Laparoscope, Gynecologic (And Accessories)). 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 Microptix Int'L, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microptix Int'L, LLC since 2007.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Microptix Int'L, LLC 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

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.

  • K982276Baho Autoclavable LaparoscopeMicroptix Int'L, LLC · 19991cites it

What has FDA decided for it lately?

  • K982276Baho Autoclavable LaparoscopeMicroptix Int'L, LLC · 19991 recall

The one decision as Microptix Int'L, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K982276(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5…Feb 23, 2022Class II