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510(k) K990354

ENDOSHEATH by Vision-Sciences, Inc. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1999
Date Received
February 5, 1999
Clearance Type
Special
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 Vision-Sciences, Inc.

  • K102733 — VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIE (May 18, 2011)
  • K100125 — VISION SCIENCES FLEXIBLE ENT SCOPE (February 25, 2010)
  • K091768 — VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU- (August 3, 2009)
  • K072180 — VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM (December 18, 2007)
  • K071127 — FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM (November 16, 2007)
  • K072073 — VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DP (August 29, 2007)
  • K072088 — FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOS (August 29, 2007)
  • K071903 — ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE (August 2, 2007)
  • K053560 — MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE (March 16, 2006)
  • K050972 — VISION-SCIENCES ENT-3000 SCOPE (April 29, 2005)

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)