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510(k) K962116

GALILEO ENDOSCOPES by Galileo Electro-Optics Corp. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1996
Date Received
May 31, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Galileo Electro-Optics Corp.

  • K981928 — GALILEO DISPOSABLE ENDOSCOPES (August 6, 1998)
  • K962256 — GALILEO HYSTEROSCOPES AND LAPAROSCOPES (December 6, 1996)
  • K934649 — GALILEO ENDOSCOPES (October 13, 1994)
  • K934707 — GALILEO ARTHROSCOPES (October 7, 1994)
  • K936280 — GALILEO ARTHROSCOPES (July 12, 1994)
  • K936279 — GALILEO ENDOSCOPES (May 16, 1994)

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  • K222587 — PatCom Distal Chip Endoscope (July 28, 2023)
  • K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (June 14, 2023)
  • K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (December 28, 2022)
  • K221581 — Single-Use Flexible Rhinolaryngoscope (November 18, 2022)