510(k) K053560

MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE by Vision-Sciences, Inc. — Product Code FAJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 16, 2006
Date Received: December 21, 2005
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cystoscope And Accessories, Flexible/Rigid
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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)
K050972 — VISION-SCIENCES ENT-3000 SCOPE (April 29, 2005)
K040984 — VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE (April 27, 2004)

Other clearances for product code FAJ

K253226 — UV5000W Handle (October 23, 2025)
K251140 — Zenflow Spring Scope (September 23, 2025)
K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (September 15, 2025)
K250797 — UV5000 Handle (September 11, 2025)
K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)
K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (August 8, 2025)
K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS- (August 1, 2025)
K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Revers (June 11, 2025)
K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G (December 18, 2024)
K243196 — Uro-G HD Cystoscope (1520) (December 13, 2024)