510(k) Report

FDA applicant

Innerdyne Medical, Inc.

Sunnyvale, CA6 decisions1993–19940 recalls

FDA records 6 decisions for Innerdyne Medical, Inc. (Sunnyvale, CA) from 1993 to 1994: 6 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and DYB (Introducer, Catheter). 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 Innerdyne Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innerdyne Medical, 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?

  • GCJLaparoscope, General & Plastic Surgery5decisions
  • DYBIntroducer, Catheter1decision

Who builds on its devices?

Later devices cite its devices 7 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.

  • K940232Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 19943cite it
  • K943253Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 19943cite it
  • K931489Intherm Radially Expanding Dilating IntroducerInnerdyne Medical, Inc. · 19931cites it

What has FDA decided for it lately?

  • K943253Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
  • K943056Single Stick Radially Expanding DilatorInnerdyne Medical, Inc. · 1994
  • K940428Innerdyne Single-Stick Radially Expanding DilatorInnerdyne Medical, Inc. · 1994
  • K940232Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
  • K932692Innerdyne Medical Laparoscopic Sphincterotomy KitInnerdyne Medical, Inc. · 1993
  • K931489Intherm Radially Expanding Dilating IntroducerInnerdyne Medical, Inc. · 1993

All 6 as Innerdyne Medical, Inc. →

Other applicant names beginning “Innerdyne”

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

Innerdyne, Inc. 12