FDA device listing

Surgical Instruments, G-U, Manual (And Accessories)

FDA device listing 1110697665 · Nissha Medical Technologies

Key facts

Owner/operator Nissha Medical Technologies
Owner/operator number 9106359
Product codes KOA
Device names KOA - Surgical Instruments, G-U, Manual (And Accessories)
Device class Class I
Classification regulations (21 CFR) 876.4730
Review panels Gastroenterology & Urology
Registered establishments Nissha Medical Technologies (Ohio), Inc.
Establishment registrations 1519132
FEI numbers 1519132
Establishment operations Contract 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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