Decision Date2021-09-03
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
KARL STORZ Flexible HD Cysto-Urethroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K212476. 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 KARL STORZ Flexible HD Cysto-Urethroscope System?
KARL STORZ Flexible HD Cysto-Urethroscope System is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K212476.
When did KARL STORZ Flexible HD Cysto-Urethroscope System receive FDA 510(k) clearance?
KARL STORZ Flexible HD Cysto-Urethroscope System received FDA 510(k) clearance on 2021-09-03, under 510(k) number K212476.
Who is the listed applicant for KARL STORZ Flexible HD Cysto-Urethroscope System?
The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KARL STORZ Flexible HD Cysto-Urethroscope System?
The FDA product code for KARL STORZ Flexible HD Cysto-Urethroscope System is FAJ.
Other records listing Karl Storz Endoscopy America, 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.
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Related Devices (Code: FAJ)
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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.K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.K253226UV5000W HandleUroviu Corporation
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.