Formalens 2000

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K863367 ↗

FDA Product Code

HQG

Device Class

Class I

Regulation

21 CFR Part 886.5844

Advisory Committee

Ophthalmic

FDA Decision

SN

• Flexible Nasopharyngo-Laryngoscope and Endosheath

  Class II

  FDA 510(k) K942265 Active Cleared 22 Dec 1995

• Modification to Vision Sciences Endosheath System

  Class II

  FDA 510(k) K024095 Active Cleared 9 Jan 2003

• Vision-Sciences Cst-2000 Flexible Cystoscope with Slide-on Endosheath System

  Class II

  FDA 510(k) K040215 Active Cleared 15 Apr 2004

• Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, DPU-5000/DPU-5050 Video Processor

  Class II

  FDA 510(k) K102733 Active Cleared 18 May 2011

• Vision-Sciences Cst-5000 Video Cystoscope with Endosheath System

  Class II

  FDA 510(k) K072180 Active Cleared 18 Dec 2007

• Flexible Hysteroscope with Endosheath System

  Class II

  FDA 510(k) K071127 Active Cleared 16 Nov 2007

See all devices from Vision-Sciences, Inc. →