Decision Date2022-11-18
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Single-Use Flexible Cystoscope is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K221580. 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 Single-Use Flexible Cystoscope?
Single-Use Flexible Cystoscope is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K221580.
When did Single-Use Flexible Cystoscope receive FDA 510(k) clearance?
Single-Use Flexible Cystoscope received FDA 510(k) clearance on 2022-11-18, under 510(k) number K221580.
Who is the listed applicant for Single-Use Flexible Cystoscope?
The FDA 510(k) record lists Hunan Vathin Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Single-Use Flexible Cystoscope?
The FDA product code for Single-Use Flexible Cystoscope is FAJ.
Other records listing Hunan Vathin Medical Instrument Co., Ltd. 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.
K250232Vathin® Video Bronchoscope SystemK251599Single-use Ureteral Access SheathK250785Single-use Flexible UreteroscopeK243117Digital Video ProcessorK242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mLK242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) View all 17 devices →
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.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.