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510(k) K953888

TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE by Vista Medical Technologies, Inc. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1995
Date Received
August 17, 1995
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 Vista Medical Technologies, Inc.

  • K021290 — VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE AC (June 28, 2002)
  • K020301 — MODIFICATION TO VISTA STEREOSCOPE SYSTEM (February 12, 2002)
  • K991303 — VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE (July 12, 1999)
  • K990635 — VISTA STEREOSCOPE SYSTEM (May 19, 1999)
  • K973436 — VISTA HEAD MOUNTED DISPLAY (December 9, 1997)
  • K971373 — VISTA SINGLE CHIP VIDEO CAMERA (May 20, 1997)
  • K970217 — VISTA ILLUMINATION SYSTEM (April 2, 1997)
  • K961800 — HEAD MOUNTED DISPLAY (September 11, 1996)

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)