FDA 510(k)

CYSTOSCOPE 0/15/30/70 DEGREES

K-Number: K960872 · 1996-05-07

Decision Date1996-05-07

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CYSTOSCOPE 0/15/30/70 DEGREES is the device name listed in this FDA 510(k) record. The listed applicant is Pollux Endoscopy, Inc.. It received FDA 510(k) clearance on 1996-05-07 under 510(k) number K960872. 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 CYSTOSCOPE 0/15/30/70 DEGREES?

CYSTOSCOPE 0/15/30/70 DEGREES is a medical device that received FDA 510(k) clearance on 1996-05-07. The listed applicant is Pollux Endoscopy, Inc.. The 510(k) number is K960872.

When did CYSTOSCOPE 0/15/30/70 DEGREES receive FDA 510(k) clearance?

CYSTOSCOPE 0/15/30/70 DEGREES received FDA 510(k) clearance on 1996-05-07, under 510(k) number K960872.

Who is the listed applicant for CYSTOSCOPE 0/15/30/70 DEGREES?

The FDA 510(k) record lists Pollux Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYSTOSCOPE 0/15/30/70 DEGREES?

The FDA product code for CYSTOSCOPE 0/15/30/70 DEGREES is FAJ.

Related Clinical Trials

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Other records listing Pollux Endoscopy, Inc. as applicant

K002214SINUSCOPE AND BACCESSORIES K953484POLLUX OA/POLLUX 30A/POLLUX 70A K943662LAPARASCOPE

Related Devices (Code: FAJ)

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 GmbH K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) Ulc K253892Strauss 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 USA K253905PrimeSight UltraView SystemCogentix Medical, Inc.K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.K253226UV5000W HandleUroviu Corporation

Official Source

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