510(k) K080740

CLEARVIEW ENDOSCOPE COVER by Invotec International, Inc. — Product Code EOB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 31, 2008
Date Received: March 17, 2008
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 Invotec International, Inc.

K122040 — INVOTEC LARYNGEAL ELECTRODE (October 31, 2013)
K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM (March 3, 2003)
K973580 — INVOTEC CLEAN PAD (December 10, 1997)
K973578 — INVOTEC EAR TAMPON (WICK) W/STRING (November 6, 1997)
K971000 — EPISTAXIS NASAL PACK (May 14, 1997)
K930114 — TRACHEOSTOMY T-TUBE (March 19, 1993)
K911041 — INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (June 4, 1991)
K911040 — INVOTEC MICROSCOPE DRAPE (June 3, 1991)
K911039 — INVOTEC EAR DRAPE (May 13, 1991)
K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

Other clearances for product code EOB

K241731 — Outlook Surgical Versa One System (8900139) (August 11, 2025)
K243639 — Portare System (FA-001) (June 5, 2025)
K243380 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (March 3, 2025)
K234096 — MonoStereo (September 19, 2024)
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)