FDA 510(k)

Strauss Surgical cystoscope, hysteroscope and accessories Instruments

Numéro K : K260271 · 2026-03-27

DemandeurAmerican Medical Endoscopy, Inc.

Date de décision2026-03-27

Code produitFAJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Strauss Surgical cystoscope, hysteroscope and accessories 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 2026-03-27 under 510(k) number K260271. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is American Medical Endoscopy, Inc.. The 510(k) number is K260271.

When did Strauss Surgical cystoscope, hysteroscope and accessories Instruments receive FDA 510(k) clearance?

Strauss Surgical cystoscope, hysteroscope and accessories Instruments received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260271.

Who is the listed applicant for Strauss Surgical cystoscope, hysteroscope and accessories 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 cystoscope, hysteroscope and accessories Instruments?

The FDA product code for Strauss Surgical cystoscope, hysteroscope and accessories Instruments is FAJ.

Essais cliniques associés

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Autres dossiers indiquant American Medical Endoscopy, Inc. en tant que demandeur

Dispositifs connexes (Code : FAJ)

K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,Olympus Winter & Ibe GmbH K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) Ulc K253892Strauss 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°,Strauss Surgical USA K253905PrimeSight UltraView SystemCogentix Medical, Inc.K253226UV5000W HandleUroviu Corporation K251140Zenflow Spring ScopeZenflow, Inc.

Source officielle

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