# Innerdyne, Inc.

- Location (FDA's records): Salt Lake City, UT
- FDA decisions: 12 (1995–2000): 12 510(k) clearances
- Product codes: GCJ (7), DYB (3), FGE (1), KNT (1)
- Predicates its devices cite: 17 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Innerdyne Medical, Inc.: 7 (https://510kreport.com/company/innerdyne-medical)
- Imagyn Medical, Inc.: 1 (https://510kreport.com/company/imagyn-medical)
- Core Dynamics, Inc.: 1 (https://510kreport.com/company/core-dynamics)
- Linvatec Corp.: 1 (https://510kreport.com/company/linvatec)

## Firms that cite its devices most
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)

## Its most-cited devices
- K950632: Innerdyne Step Trocar Expandable Port, Step (1995), cited by 3
- K950658: Innerdyne Step Trocar Expandable Port, Step: (1995), cited by 3
- K972684: Innerdyne Radially Expanding Vascular Access System (1997), cited by 1
- K961940: Innerdyne Step Trocar Expandable Port, Onestep (1996), cited by 1

## Recent decisions
- K992668: Innerdyne Radially Expanding Vascular Access System (Revas) (May 26, 2000)
- K990854: Innerdyne Radially Expanding Dilation, Red Device (Aug 2, 1999)
- K990493: Innerdyne Generic Radially Expanding Dilation, G-Red Device (May 18, 1999)
- K982417: Innerdyne Step Trocar Expandable Port, Step (Oct 7, 1998)
- K980578: Innerdyne Radially Expanding Vascular Access System (Heparin Coated) (Sep 11, 1998)
- K972684: Innerdyne Radially Expanding Vascular Access System (Oct 10, 1997)
- K971230: Sherwood Medical Company , Kangaroo, Entristar, Percutaneous Gastrostomy Kit (Jun 13, 1997)
- K970754: Innerdyne Step Trocar Expanable Port, Open Step (Apr 21, 1997)

Source page: https://510kreport.com/company/innerdyne