Strauss Surgical cystoscope, hysteroscope and accessories Instruments— 510(k) K260271
Substantially EquivalentAmerican Medical Endoscopy, Inc.
FDA 510(k) clearance K260271 for Strauss Surgical cystoscope, hysteroscope and accessories Instruments, Substantially Equivalent on 2026-03-27. Applicant: American Medical Endoscopy, Inc.. Device class: 2.
Summary
American Medical Endoscopy's record names "Strauss Surgical cystoscope, hysteroscope and accessories Instruments" under FAJ, flexible or rigid cystoscopes and accessories. The record doesn't list individual instruments.
Class II, 21 CFR 876.1500. It was a Traditional 510(k), and Gastroenterology and Urology is both the classification panel and the review panel.
American Medical Endoscopy filed from Doral, Florida. The decision came 58 calendar days after FDA received it (January 28 to March 27, 2026).
Clearance details
- Applicant
- American Medical Endoscopy, Inc.
- Product code
- Product code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Doral, FL, US
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More clearances from American Medical Endoscopy, Inc.
view all- K253020 — Strauss Surgical Resection Instruments
- K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.