FDA device listing

FlowStasis,FlowStasis - 3 Pack,FlowStasis Single-Pack,FlowStasis Suture Retention Device,General Instruments,GENERAL…

FDA device listing 1786210648 · STRYKER CORP.

Key facts

Proprietary names FlowStasis,FlowStasis - 3 Pack,FlowStasis Single-Pack,FlowStasis Suture Retention Device,General Instruments,GENERAL INSTRUMENTS,SUTURE BUTTON
Owner/operator STRYKER CORP.
Owner/operator number 1811755
Product codes KGS
Device names KGS - Retention Device, Suture
Device class Class I
Classification regulations (21 CFR) 878.4930
Review panels General & Plastic Surgery
Registered establishments Inari Medical, Inc., WRIGHT MEDICAL TECHNOLOGY, INC.
Establishment registrations 1043534, 3010667733, 3020347218
FEI numbers 1043534, 3010667733, 3020347218
Establishment operations Complaint File Establishment, Specification Developer, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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