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510(k) K000905

URETHROTOME 8667.XXX AND 8670.XXX by Richard Wolf Medical Instruments Corp. — Product Code EZO

K000905 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "URETHROTOME 8667.XXX AND 8670.XXX". The FDA issued a decision of Substantially Equivalent on May 12, 2000. The device falls under product code EZO (Urethrotome), a Class II device regulated under 21 CFR 876.4770. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2000
Date Received
March 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urethrotome
Device Class
Class II
Regulation Number
876.4770
Review Panel
GU
Submission Type

Other clearances by Richard Wolf Medical Instruments Corp.

  • K151282 — core nova Complete Operating Room Endoscopy (January 12, 2016)
  • K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (April 3, 2013)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR (August 3, 2012)
  • K090776 — MEGAPULSE LASER SYSTEM AND FIBERS (June 2, 2009)
  • K080617 — POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (June 27, 2008)
  • K080977 — 3 CCD ENDOCAM 5550 (May 14, 2008)
  • K071292 — VIEW MD OFFICE SYSTEM, MODEL 41066.5540 (July 19, 2007)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K051276 — HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM (October 28, 2005)

Other clearances for product code EZO

  • K950719 — OES UROLOGY (December 11, 1996)
  • K945686 — KARL STORZ KNIVES, CURETTES (February 13, 1995)
  • K934730 — KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (January 11, 1994)
  • K904939 — FLEXIBLE AND RIGID URETEROTOME SYSTEM (January 7, 1992)

FDA data resources