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FDA 510(k)

ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)

K-Number: K120766 · 2012-09-11

ApplicantProsurg, Inc.
Decision Date2012-09-11
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2012-09-11 under 510(k) number K120766. 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 ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)?

ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 2012-09-11. The listed applicant is Prosurg, Inc.. The 510(k) number is K120766.

When did ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) receive FDA 510(k) clearance?

ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) received FDA 510(k) clearance on 2012-09-11, under 510(k) number K120766.

Who is the listed applicant for ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)?

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

What is the FDA product code for ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)?

The FDA product code for ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) is FAJ.

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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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