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510(k) K120766

ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) by Prosurg, Inc. — Product Code FAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2012
Date Received
March 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Prosurg, Inc.

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  • K152466 — Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) (May 19, 2016)
  • K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) (April 29, 2016)
  • K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & AC (December 28, 2007)
  • K071138 — CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM (August 15, 2007)
  • K070737 — XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES (July 25, 2007)
  • K070846 — MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM (July 2, 2007)
  • K060326 — LASERTX - DIODE LASER & DELIVERY SYSTEM (April 5, 2006)
  • K050488 — TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES (April 1, 2005)
  • K042780 — NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (February 3, 2005)

Other clearances for product code FAJ

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  • K251140 — Zenflow Spring Scope (September 23, 2025)
  • K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (September 15, 2025)
  • K250797 — UV5000 Handle (September 11, 2025)
  • K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)
  • K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (August 8, 2025)
  • K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS- (August 1, 2025)
  • K250269 — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Revers (June 11, 2025)
  • K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G (December 18, 2024)
  • K243196 — Uro-G HD Cystoscope (1520) (December 13, 2024)