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510(k) K993041

OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT by The Olympus Optical Co. — Product Code FAJ

K993041 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT". The FDA issued a decision of Substantially Equivalent on March 30, 2000. The device falls under product code FAJ (Cystoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2000
Date Received
September 10, 1999
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 The Olympus Optical Co.

  • K032066 — SONOSURG SYSTEM (October 3, 2003)
  • K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (March 24, 2003)
  • K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (February 12, 2003)
  • K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SE (January 31, 2003)
  • K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H (December 23, 2002)
  • K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES (November 29, 2002)
  • K012074 — XBO1-824-18/19/20 BIOPSY FORCEPS (September 25, 2001)
  • K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (May 15, 2001)

Other clearances for product code FAJ

  • K260649 — OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 1 (May 21, 2026)
  • K253696 — CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse D (May 11, 2026)
  • K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x (April 16, 2026)
  • K253905 — PrimeSight UltraView System (April 7, 2026)
  • K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments (March 27, 2026)
  • 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)

FDA data resources