# K961506: Microspan Hysteroscope Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical, Inc.
- Decided: Jul 3, 1996 after 75 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Sheaths: named in the summary without a submission number
- (no number) Olympus Hysteroscope 4/5 mm System: named in the summary without a submission number
- (no number) Circon ACMI Office Operative Hysteroscope Sheath: named in the summary without a submission number
- (no number) Karl Storz Mini-Hysteroscopy Operating Sheath: named in the summary without a submission number

## Most influential descendants
- K982630: Medworks Visualization Insemination Catheter (1999), 0 descendants of its own

## Indications for use
The MicroSpan Hysteroscope Sheath is indicated for use in providing access to the uterine cavity for the Imagyn Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.

Source page: https://510kreport.com/device/K961506
Methodology: https://510kreport.com/methodology