Company · US
Richard Wolf Medical Instruments Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2024. Name variants (Inc, Corp, punctuation) are merged.
153510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 28 |
| HRX | Arthroscope | 17 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 13 |
| HET | Laparoscope, Gynecologic (And Accessories) | 9 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 8 |
| HIF | Insufflator, Laparoscopic | 8 |
| HIH | Hysteroscope (And Accessories) | 7 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 5 |
| FFK | Lithotriptor, Electro-Hydraulic | 4 |
| FJL | Resectoscope | 4 |
| GCT | Light Source, Endoscope, Xenon Arc | 4 |
| GWG | Endoscope, Neurological | 3 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 2 |
| FBO | Cystourethroscope | 2 |
| FGA | Kit, Nephroscope | 2 |
| GCM | Endoscope, Rigid | 2 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2024 | K231291 | Perforated Baskets Richard Wolf Medical Instruments Corporation | KCT |
| Mar 22, 2023 | K230194 | HF Surgery Generator 400KHZ Richard Wolf Medical Instruments Corporation | GEI |
| Jun 14, 2022 | K212808 | Logic Hd camera head green, System green Richard Wolf Medical Instruments Corporation | FET |
| Oct 1, 2021 | K211332 | D Camera Controller Richard Wolf Medical Instruments Corporation | FET |
| May 14, 2021 | K203226 | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / Richard Wolf Medical Instruments Corporation | GCM |
| Jan 15, 2021 | K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 Richard Wolf Medical Instruments Corporation | FGB |
| Jun 23, 2020 | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 Richard Wolf Medical Instruments Corporation | FET |
| May 3, 2019 | K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF Richard Wolf Medical Instruments Corporation | FGB |
| Jun 28, 2018 | K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD Richard Wolf Medical Instruments Corporation | FET |
| Apr 5, 2017 | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM Richard Wolf Medical Instruments Corporation | GEI |
| Jan 11, 2017 | K161204 | ENDOCAM Flex HD Camera System 5521 Richard Wolf Medical Instruments Corporation | FET |
| Jan 12, 2016 | K151282 | core nova Complete Operating Room Endoscopy Richard Wolf Medical Instruments Corp. | ODA |
| Apr 3, 2013 | K130423 | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 Richard Wolf Medical Instruments Corp. | FET |
| Sep 20, 2012 | K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 Richard Wolf Medical Instruments Corp. | FCW |
| Aug 3, 2012 | K120898 | KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA Richard Wolf Medical Instruments Corp. | OTJ |
| Jun 2, 2009 | K090776 | MEGAPULSE LASER SYSTEM AND FIBERS Richard Wolf Medical Instruments Corp. | GEX |
| Jun 27, 2008 | K080617 | POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES Richard Wolf Medical Instruments Corp. | HRX |
| May 14, 2008 | K080977 | 3 CCD ENDOCAM 5550 Richard Wolf Medical Instruments Corp. | GCJ |
| Jul 19, 2007 | K071292 | VIEW MD OFFICE SYSTEM, MODEL 41066.5540 Richard Wolf Medical Instruments Corp. | GCJ |
| Mar 22, 2007 | K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES Richard Wolf Medical Instruments Corp. | FJL |
| Oct 28, 2005 | K051276 | HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM Richard Wolf Medical Instruments Corp. | OCZ |
| Oct 5, 2005 | K051176 | FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 Richard Wolf Medical Instruments Corp. | FAJ |
| Mar 18, 2005 | K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES Richard Wolf Medical Instruments Corp. | FJL |
| Aug 19, 2004 | K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 Richard Wolf Medical Instruments Corp. | FJL |
| Jul 29, 2004 | K031858 | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES Richard Wolf Medical Instruments Corp. | GWG |
| Jul 9, 2004 | K041321 | VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM Richard Wolf Medical Instruments Corp. | HET |
| Dec 23, 2003 | K033113 | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 Richard Wolf Medical Instruments Corp. | HIH |
| Oct 30, 2003 | K030082 | POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 Richard Wolf Medical Instruments Corp. | HRX |
| Mar 21, 2003 | K022198 | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 Richard Wolf Medical Instruments Corp. | GWG |
| Jan 29, 2003 | K023659 | 1-CCD ENDOCAM 5520 SYSTEM Richard Wolf Medical Instruments Corp. | FET |
| Jan 17, 2003 | K023813 | BIPOLAR FORCEPS Richard Wolf Medical Instruments Corp. | GEI |
| Sep 18, 2002 | K020255 | RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 Richard Wolf Medical Instruments Corp. | ODA |
| Jan 10, 2002 | K010033 | LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 Richard Wolf Medical Instruments Corp. | GCJ |
| Oct 19, 2001 | K012309 | RIWO SYSTEM TRAYS Richard Wolf Medical Instruments Corp. | FEB |
| Sep 17, 2001 | K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX Richard Wolf Medical Instruments Corp. | FFK |
| Aug 27, 2001 | K002328 | SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR Richard Wolf Medical Instruments Corp. | HIF |
| Aug 10, 2001 | K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 Richard Wolf Medical Instruments Corp. | FBO |
| May 9, 2001 | K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) Richard Wolf Medical Instruments Corp. | FFK |
| Apr 10, 2001 | K002000 | MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; Richard Wolf Medical Instruments Corp. | GEI |
| Apr 4, 2001 | K003417 | MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET Richard Wolf Medical Instruments Corp. | HET |
| Mar 2, 2001 | K000180 | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP Richard Wolf Medical Instruments Corp. | HIF |
| Jan 8, 2001 | K003164 | TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM Richard Wolf Medical Instruments Corp. | HET |
| Jun 5, 2000 | K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 Richard Wolf Medical Instruments Corp. | FGA |
| May 26, 2000 | K000673 | HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 Richard Wolf Medical Instruments Corp. | HIH |
| May 12, 2000 | K000905 | URETHROTOME 8667.XXX AND 8670.XXX Richard Wolf Medical Instruments Corp. | EZO |
| Mar 30, 2000 | K000046 | KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) Richard Wolf Medical Instruments Corp. | HRX |
| Mar 6, 2000 | K994363 | INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) Richard Wolf Medical Instruments Corp. | HRX |
| Dec 10, 1999 | K993103 | ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES Richard Wolf Medical Instruments Corp. | GCM |
| Nov 23, 1999 | K991906 | LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT Richard Wolf Medical Instruments Corp. | HIF |
| Oct 25, 1999 | K990397 | FLEXIBLE FIBERSCOPES & ACCESSORIES Richard Wolf Medical Instruments Corp. | HRX |
Newest 50 of 153.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2019 | Richard Wolf Medical Instruments Corp. E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product U Terminated |
HIH | K980302 |
| May 19, 2016 | Richard Wolf Medical Instruments Corp. Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes Terminated |
HHI | None listed |
| Feb 29, 2016 | Richard Wolf Medical Instruments Corp. The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures. Terminated |
FWE | None listed |
| Feb 9, 2016 | Richard Wolf Medical Instruments Corp. Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut har Terminated |
HRX | K984304 |
| Feb 9, 2016 | Richard Wolf Medical Instruments Corp. Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut har Terminated |
HRX | K984304 |
| Feb 9, 2016 | Richard Wolf Medical Instruments Corp. Reuseable rotary blade/abrader, product number 899751305.
The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone Terminated |
HRX | K984304 |
| Mar 3, 2015 | Richard Wolf Medical Instruments Corp. The I-Cart is used to store, transport, and power video equipment used in medical procedures. Terminated |
KMI | None listed |
| Nov 6, 2014 | Richard Wolf Medical Instruments Corp. The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouc Terminated |
KNH | None listed |
| Nov 4, 2013 | Richard Wolf Medical Instruments Corp. Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/ Terminated |
FJL | K062720 |
| Nov 17, 2009 | Richard Wolf Medical Instruments Corp. Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Verno Terminated |
HGB | None listed |
| Aug 24, 2006 | Richard Wolf Medical Instruments Corp. Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, Terminated |
HIF | K000180 |
| Feb 11, 2004 | Richard Wolf Medical Instruments Corp. Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder st Terminated |
JOL | K011911 |