FDA device listing

BAHO AUTOCLAVABLE LAPAROSCOPE

FDA device listing 1655109270 · INNOVIEW GMBH

Key facts

Proprietary names BAHO AUTOCLAVABLE LAPAROSCOPE
Owner/operator INNOVIEW GMBH
Owner/operator number 9026517
Premarket submissions K982276
Product codes HET
Device names HET - Laparoscope, Gynecologic (And Accessories)
Device class Class II
Classification regulations (21 CFR) 884.1720
Review panels Obstetrics/Gynecology
Registered establishments INNOVIEW GMBH
Establishment registrations 9615001
FEI numbers 3003922255
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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

Browse all FDA device listings