FDA 510(k)

Strauss Surgical Resection Instruments

N.º K: K253020 · 2026-06-04

SolicitanteAmerican Medical Endoscopy, Inc.

Fecha de decisión2026-06-04

Código de productoHIH

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Strauss Surgical Resection Instruments is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Endoscopy, Inc.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253020. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Strauss Surgical Resection Instruments?

Strauss Surgical Resection Instruments is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is American Medical Endoscopy, Inc.. The 510(k) number is K253020.

When did Strauss Surgical Resection Instruments receive FDA 510(k) clearance?

Strauss Surgical Resection Instruments received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253020.

Who is the listed applicant for Strauss Surgical Resection Instruments?

The FDA 510(k) record lists American Medical Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Strauss Surgical Resection Instruments?

The FDA product code for Strauss Surgical Resection Instruments is HIH.

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Otros registros que enlistan a American Medical Endoscopy, Inc. como solicitante

K260271Strauss Surgical cystoscope, hysteroscope and accessories Instruments K251652Strauss 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

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Fuente oficial

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