# K971188: Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 27, 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 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) Karl Storz Endoscopy Telescopes and accessories: named in the summary without a submission number
- (no number) Henke-Sass Wolf Hysteroscopes and accessories: named in the summary without a submission number
- (no number) Circon ACMI Semi-rigid and Flexible Manual Instruments: named in the summary without a submission number
- (no number) Richard Wolfe Semi-rigid and Flexible Manual Instruments: named in the summary without a submission number

## Most influential descendants
- K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224 (2002), 14 descendants of its own
- K112134: Truclear Operative Hysteroscope (2011), 7 descendants of its own
- K152143: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C (2015), 6 descendants of its own
- K190372: Aveta System (2019), 4 descendants of its own
- K091465: Myosure Rod Lens Hysteroscope (2009), 4 descendants of its own

## Indications for use
Smith & Nephew Images Hysteroscopes and accessories are used to permit viewing of the cervial canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for endoscopic examination and treatment of the ceriveal canal and uterine cavity.

Source page: https://510kreport.com/device/K971188
Methodology: https://510kreport.com/methodology