# K253020: Strauss Surgical Resection Instruments

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Endoscopy, Inc.
- Decided: Jun 4, 2026 after 258 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: * Dilation of the urethra, and cold-slitting of urethral strictures * Trans-urethral incision and resection of the prostate * Trans-urethral removal of bladder tumor * Trans-cervical resection and ablation of the endometrium * Trans-cervical resection of fibroids

Source page: https://510kreport.com/device/K253020
Methodology: https://510kreport.com/methodology