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FDA 510(k)

FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735

K-Number: K012929 · 2001-11-19

ApplicantCircon Video
Decision Date2001-11-19
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 2001-11-19 under 510(k) number K012929. 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 FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735?

FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 is a medical device that received FDA 510(k) clearance on 2001-11-19. The listed applicant is Circon Video. The 510(k) number is K012929.

When did FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 receive FDA 510(k) clearance?

FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 received FDA 510(k) clearance on 2001-11-19, under 510(k) number K012929.

Who is the listed applicant for FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735?

The FDA 510(k) record lists Circon Video as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735?

The FDA product code for FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 is FAJ.

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Other records listing Circon Video 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.

K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,K011876DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROSK012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPEK012925DUR-8, MODELS DUR-8K012265METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088

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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.

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