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510(k) K093665

ENDO SMARTCAP by Byrne Medical, Inc. — Product Code FAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2009
Date Received
November 25, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Byrne Medical, Inc.

  • K113310 — ENDOGATER AVANTAGE CO2 INSUFFLATOR (June 20, 2012)
  • K113119 — ENDOGATOR ADVANTAGE IRRIGATION PUMP (April 27, 2012)
  • K102855 — UNIVERSAL IRRIGATION SOLUTION HYBRID (November 19, 2010)
  • K102581 — DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 (November 8, 2010)
  • K102409 — DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 (November 4, 2010)
  • K092090 — ERBELIFT HAND PUMP AND FLEXIBLE PROBE (November 30, 2009)
  • K092429 — ENDOGATOR (November 19, 2009)
  • K090851 — DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301 (July 2, 2009)
  • K060962 — ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 (April 19, 2006)
  • K033695 — IRRIGATION CHANNEL TUBING, MODEL 100135 (December 23, 2003)

Other clearances for product code FAJ

  • K253226 — UV5000W Handle (October 23, 2025)
  • 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)