Decision Date2026-03-27
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
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.
Frequently Asked Questions
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.
Other records listing American Medical Endoscopy, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K253020Strauss Surgical Resection InstrumentsK251652Strauss 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
Related Devices (Code: FAJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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 GmbHK253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) UlcK253892Strauss 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 USAK253905PrimeSight UltraView SystemCogentix Medical, Inc.K253226UV5000W HandleUroviu CorporationK251140Zenflow Spring ScopeZenflow, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.