Decision Date1999-12-15
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AED CYSTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 1999-12-15 under 510(k) number K993689. 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 AED CYSTOSCOPE?
AED CYSTOSCOPE is a medical device that received FDA 510(k) clearance on 1999-12-15. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K993689.
When did AED CYSTOSCOPE receive FDA 510(k) clearance?
AED CYSTOSCOPE received FDA 510(k) clearance on 1999-12-15, under 510(k) number K993689.
Who is the listed applicant for AED CYSTOSCOPE?
The FDA 510(k) record lists National Advanced Endoscopy Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AED CYSTOSCOPE?
The FDA product code for AED CYSTOSCOPE is FAJ.
Related Clinical Trials
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Other records listing National Advanced Endoscopy Devices, 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)
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.