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Richard Wolf Medical Instruments Corp.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
142
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1957-2019Class IIE-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray May 23, 2019
Z-2608-2016Class IIConical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction wMay 19, 2016
Z-1188-2016Class IIThe Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used toFebruary 29, 2016
Z-0789-2016Class IIReuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accesNovember 25, 2015
Z-0790-2016Class IIReuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attaNovember 25, 2015
Z-0791-2016Class IIReuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attaNovember 25, 2015
Z-1240-2015Class IIThe I-Cart is used to store, transport, and power video equipment used in medical procedures.December 10, 2014
Z-0037-2015Class IIThe Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is pJuly 9, 2014
Z-0145-2014Class IIIndividual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, September 18, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K151282core nova Complete Operating Room EndoscopyJanuary 12, 2016
K130423THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525April 3, 2013
K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2September 20, 2012
K120898KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAugust 3, 2012
K090776MEGAPULSE LASER SYSTEM AND FIBERSJune 2, 2009
K080617POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIESJune 27, 2008
K0809773 CCD ENDOCAM 5550May 14, 2008
K071292VIEW MD OFFICE SYSTEM, MODEL 41066.5540July 19, 2007
K062720S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODESMarch 22, 2007
K051276HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEMOctober 28, 2005
K051176FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066October 5, 2005
K042523RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIESMarch 18, 2005
K041610MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207August 19, 2004
K031858NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPJuly 29, 2004
K041321VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEMJuly 9, 2004
K033113UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FDecember 23, 2003
K030082POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851October 30, 2003
K022198ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452March 21, 2003
K0236591-CCD ENDOCAM 5520 SYSTEMJanuary 29, 2003
K023813BIPOLAR FORCEPSJanuary 17, 2003