# American Medical Endoscopy, Inc.

- Location (FDA's records): Doral, FL
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: FAJ (2), HIH (1)
- 510(k) review time since 2016: median 64 days, against 123 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Henke-Sass, Wolf GmbH: 1 (https://510kreport.com/company/henke-sass-wolf)
- Schoelly Fiberoptic GmbH: 1 (https://510kreport.com/company/schoelly-fiberoptic)

## Firms that cite its devices most
- Strauss Surgical USA: 1 (https://510kreport.com/company/strauss-surgical-usa)

## Its most-cited devices
- 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 (2025), cited by 1

## Recent decisions
- K253020: Strauss Surgical Resection Instruments (Jun 4, 2026)
- K260271: Strauss Surgical cystoscope, hysteroscope and accessories Instruments (Mar 27, 2026)
- 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 (Aug 1, 2025)

Source page: https://510kreport.com/company/american-medical-endoscopy