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510(k) K994223

NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 by Richard Wolf Medical Instruments Corp. — Product Code FGA

K994223 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20". The FDA issued a decision of Substantially Equivalent on June 5, 2000. The device falls under product code FGA (Kit, Nephroscope), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2000
Date Received
December 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Nephroscope
Device Class
Class II
Regulation Number
876.1500
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 FGA

  • K232370 — Percutaneous Nephroscope System (May 1, 2024)
  • K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (February 9, 2016)
  • K072594 — GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (December 13, 2007)
  • K950433 — KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES (March 15, 1995)
  • K940594 — KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE (September 9, 1994)
  • K922826 — FLEXIBLE FIBER OPTIC ENDOSCOPE (February 19, 1993)
  • K853486 — OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (September 12, 1985)
  • K791182 — ACMI RIGI-FLEX NEPHORSCOPE (July 30, 1979)
  • K770729 — PYELOSCOPE SYSTEM (April 28, 1977)

FDA data resources