510(k) Report

FDA applicant

Inlet Medical, Inc.

Findley, MN2 decisions1993–19990 recalls

FDA records 2 decisions for Inlet Medical, Inc. (Findley, MN) from 1993 to 1999: 2 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Inlet Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Inlet Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Inlet Medical, 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?

  • GCJLaparoscope, General & Plastic Surgery2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K984600Metra PS Procedure KitInlet Medical, Inc. · 1999
  • K923528Inlet Irrigation/Aspiration Valve and ProbesInlet Medical, Inc. · 1993

All 2 as Inlet Medical, Inc. →