Strauss Surgical USA · Class II · Cleared Apr 16, 2026
| K-number | K253892 |
| Device name | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, |
| Applicant | Strauss Surgical USA |
| Product code | FAJ |
| Device class | Class II |
| Decision date | Apr 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
Strauss Surgical Cystoscopes and Hysteroscopes are rigid endoscopes used to illuminate and visualize the male urethra, prostate, and bladder (cystoscopes) or the cervical canal and uterine cavity (hysteroscopes) for performing diagnostic and surgical procedures. These devices consist of a fiber optic cable, image transmission system, and eyepiece, with multiple models varying in diameter (2.9 mm or 4 mm), length (302 mm), viewing direction (0°–70°), and field of view (standard or wide angle).
The subject and predicate devices have identical technological characteristics: both use external light transmitted through fiber optic cables to the endoscope tip, with images returned via rigid lens systems. Both feature the same diameter and length insertion tubes (2.9 mm or 4 mm / 302 mm), identical Direction of View (0°–70°) and Field of View (63°–85°) parameters, no working channel, metal and stainless steel outer surfaces, and require identical reprocessing methods (manual/automated cleaning, high-level disinfection, and steam sterilization).
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov