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510(k) K933105

XOMED-TREACE RIGID ROD LENS ENDOSCOPE by Xomed-Treace, Inc. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1994
Date Received
June 25, 1993
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 Xomed-Treace, Inc.

  • K940028 — ENDOSCOPE SHEATH (March 24, 1995)
  • K941407 — TYMPANOSTOMY (VENTILATION) TUBE (March 14, 1995)
  • K945659 — BLACKSTAR(TM) STAR SYSTEM (January 9, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K933672 — XOMED-TREACE SCOPESHEATH (July 18, 1994)
  • K934426 — NERVE INTEGRITY MONITOR-2 (NIM-2 XL) (May 13, 1994)
  • K925640 — XOMED-TREACE EMG ENDOTRACHEAL TUBEEN (August 17, 1993)
  • K922880 — XOMED TREACE JET VENTILATION TUBE (April 15, 1993)
  • K923830 — XOMED-TREACE ALPHASCOPE (November 9, 1992)
  • K912753 — XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL (September 23, 1991)

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  • K232435 — Rhinolaryngoscope system (April 26, 2024)
  • K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507. (August 3, 2023)
  • 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)