Richard Wolf Medical Instruments Corp.
FDA Regulatory Profile
Richard Wolf Medical Instruments Corp. appears in FDA public data with 9 recalls, 142 510(k) clearances, 9 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1957-2019, Class II) was initiated on May 23, 2019. Its most recent 510(k) clearance was granted on January 12, 2016.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 142
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1957-2019 | Class II | E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray | May 23, 2019 |
| Z-2608-2016 | Class II | Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction w | May 19, 2016 |
| Z-1188-2016 | Class II | The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to | February 29, 2016 |
| Z-0789-2016 | Class II | Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or acces | November 25, 2015 |
| Z-0790-2016 | Class II | Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an atta | November 25, 2015 |
| Z-0791-2016 | Class II | Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an atta | November 25, 2015 |
| Z-1240-2015 | Class II | The I-Cart is used to store, transport, and power video equipment used in medical procedures. | December 10, 2014 |
| Z-0037-2015 | Class II | The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is p | July 9, 2014 |
| Z-0145-2014 | Class II | Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, | September 18, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 8850XX KEYPORT TROC | 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 |
| K051176 | FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 | October 5, 2005 |
| K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES | March 18, 2005 |
| K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 | August 19, 2004 |
| K031858 | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIP | July 29, 2004 |
| K041321 | VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM | July 9, 2004 |
| K033113 | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, F | December 23, 2003 |
| K030082 | POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 | October 30, 2003 |
| K022198 | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 | March 21, 2003 |
| K023659 | 1-CCD ENDOCAM 5520 SYSTEM | January 29, 2003 |
| K023813 | BIPOLAR FORCEPS | January 17, 2003 |