FDA applicant

Innerdyne, Inc.

Salt Lake City, UT12 decisions1995–20001 recall

FDA records 12 decisions for Innerdyne, Inc. (Salt Lake City, UT) from 1995 to 2000: 12 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and DYB (Introducer, Catheter). Its devices cite 17 predicates, 7 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Innerdyne, Inc. since 2007.

Recalls per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Innerdyne, 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

Other applicant names beginning “Innerdyne”

FDA records each applicant name separately; these may or may not be the same firm.

Innerdyne Medical, Inc. 6

Innerdyne, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Innerdyne”