# K071127: Flexible Hysteroscope with Endosheath System

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Nov 16, 2007 after 207 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921244 (1992). 17 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040215: Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System, Vision-Sciences, Inc. (2004) Summary page 1.
- K053560: Modified Endosheath System for Vsi Flexible Cystoscope, Vision-Sciences, Inc. (2006) Summary page 1.
- K891451: Olympus Hyf-P Flexible Hysterofiberscope, Olympus Corp. (1989) Summary page 1.
- (no number) Olympus HYF-1T Flexible Fiberoptic Hysteroscope: named in the summary without a submission number

## Most influential descendants
- K181909: Luminelle DTx Hysteroscopy System (2018), 3 descendants of its own
- K190827: Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid (2019), 2 descendants of its own
- K192278: Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) (2019), 1 descendant of its own
- K253905: PrimeSight UltraView System (2026), 0 descendants of its own
- K210512: LUMINELLE DTx System (2021), 0 descendants of its own

## Indications for use
The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures. The CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures. Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.

Source page: https://510kreport.com/device/K071127
Methodology: https://510kreport.com/methodology