Home / 510(k) Clearances / K994223

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

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)