FDA 510(k)

BAHO AUTOCLAVABLE CYSTOSCOPE

K-Number: K992983 · 1999-10-07

ApplicantInnovative Endoscopy Components, LLC

Decision Date1999-10-07

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BAHO AUTOCLAVABLE CYSTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Endoscopy Components, LLC. It received FDA 510(k) clearance on 1999-10-07 under 510(k) number K992983. 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 BAHO AUTOCLAVABLE CYSTOSCOPE?

BAHO AUTOCLAVABLE CYSTOSCOPE is a medical device that received FDA 510(k) clearance on 1999-10-07. The listed applicant is Innovative Endoscopy Components, LLC. The 510(k) number is K992983.

When did BAHO AUTOCLAVABLE CYSTOSCOPE receive FDA 510(k) clearance?

BAHO AUTOCLAVABLE CYSTOSCOPE received FDA 510(k) clearance on 1999-10-07, under 510(k) number K992983.

Who is the listed applicant for BAHO AUTOCLAVABLE CYSTOSCOPE?

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

What is the FDA product code for BAHO AUTOCLAVABLE CYSTOSCOPE?

The FDA product code for BAHO AUTOCLAVABLE CYSTOSCOPE is FAJ.

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Other records listing Innovative Endoscopy Components, LLC as applicant

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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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