# K972426: Microspan Gold Hysteroscope and Microspan Hysteroscope Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical, Inc.
- Decided: Sep 23, 1997 after 88 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 MicroSpan Hysteroscope: named in the summary without a submission number
- (no number) Imagyn MicroLap-Gold Laparoscope: named in the summary without a submission number
- (no number) Optimed Technologies Rigid Fiber Optic Hysteroscope: named in the summary without a submission number
- (no number) MicroSpan Hysteroscope Sheath: named in the summary without a submission number

## Most influential descendants
- K092421: Alphahysteroscope, Fiberoptic, Operative and Diagnostic (2010), 0 descendants of its own

## Indications for use
The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.

Source page: https://510kreport.com/device/K972426
Methodology: https://510kreport.com/methodology