# K972210: Resectoscope Safety Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Conceptus, Inc.
- Decided: Sep 5, 1997 after 86 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Gynecare VersaPoint System: named in the summary without a submission number
- (no number) FemRx PEARL Loop/OPERA System: named in the summary without a submission number
- (no number) Karl Storz Continuous Flow Resectoscope: named in the summary without a submission number
- (no number) Conceptus FUTURA Sheath for Urological indications: named in the summary without a submission number

## Indications for use
The ERA Sheath is indicated for use during resection and/or ablation of unwanted or diseased uterine tissue.

Source page: https://510kreport.com/device/K972210
Methodology: https://510kreport.com/methodology