K-numberK253892
Device nameStrauss 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°,
ApplicantStrauss Surgical USA
Product codeFAJ
Device classClass II
Decision dateApr 16, 2026
DecisionSubstantially Equivalent
Regulation876.1500
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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).

Technological characteristics

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).

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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