# K961688: Microspan Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical, Inc.
- Decided: Oct 15, 1996 after 167 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
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Imagyn Hysteroscope: named in the summary without a submission number
- (no number) Imagyn MicroLap Laparoscope: named in the summary without a submission number
- (no number) Karl Storz Miniscope Straight Forward Telescope: named in the summary without a submission number
- (no number) Optimed Technologies Rigid Fiber Optic Hysteroscope: named in the summary without a submission number

## Most influential descendants
- K123151: Endosee Model 8000 U-Scope (2013), 20 descendants of its own
- K132384: U-Scope 8000 System with HSC+Emb Cannula (2014), 19 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own
- K202445: Hystero-V Hysteroscope (2021), 4 descendants of its own
- K183020: Endosee System (2019), 4 descendants of its own

## Indications for use
The MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K961688
Methodology: https://510kreport.com/methodology