Data / Medical devices / United States / Millennium Surgical Corp
Millennium Surgical Corp: FDA-registered device maker in Schaumburg, IL, United States, 63 510(k) clearances
Millennium Surgical Corp is registered with the FDA (registration 3004215117) in Schaumburg, IL, United States. It lists 247 device types. The FDA files 63 510(k) clearances under its listings, the newest dated March 22, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004215117
- Address
- 626 Cooper Ct, Schaumburg, IL, United States, 60173
- Owner or operator
- Avalign Technologies (10051835)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- May 9, 2016
- Registered through
- 2027
- Brand names listed
- Millennium, Stone Clamp Locking Device
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 22, 2019 | K181173 | ELMED Laparoscopic Instruments and Accessories | GCJ | Substantially Equivalent | Elmed Incorporated | accessdata.fda.gov |
| April 5, 2018 | K172368 | Bipolar Micro-Coagulation Forceps | GEI | Substantially Equivalent | Gunter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| February 29, 2016 | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | HAE | Substantially Equivalent | K2 Medical GmbH & Co. KG | accessdata.fda.gov |
| October 29, 2013 | K130117 | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | HOZ | Substantially Equivalent | Network Medical Products, Ltd. | accessdata.fda.gov |
| May 10, 2013 | K123478 | STINGRAY BIPOLAR FORCEPS | GEI | Substantially Equivalent | Stingray Surgical Products | accessdata.fda.gov |
| November 9, 2011 | K102752 | STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS | GEI | Substantially Equivalent | Stingray Surgical Products, Inc. | accessdata.fda.gov |
| November 8, 2011 | K111930 | ACKERMANN EUROPCLIP | FZP | Substantially Equivalent | Ackermann Instrumente GmbH | accessdata.fda.gov |
| May 10, 2011 | K110121 | WEXLER ENDOSCOPE ACCESSORIES | GCJ | Substantially Equivalent | Microsurgical Laboratories,Inc.Dba Wexler Surgical | accessdata.fda.gov |
| November 18, 2010 | K102146 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| September 10, 2010 | K100736 | KIRSCHNER AND GUIDE WIRES | HTY | Substantially Equivalent | Smt Schilling Metalltechnik GmbH | accessdata.fda.gov |
| August 31, 2010 | K100518 | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | DWP | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| April 29, 2010 | K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | HDA | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| March 11, 2010 | K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| December 3, 2009 | K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | HCZ | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| October 26, 2009 | K092544 | INSTRUMED VASCULAR CLAMPS | DXC | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| October 2, 2009 | K091721 | CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 | GEH | Substantially Equivalent | New Medical Technologies GmbH | accessdata.fda.gov |
| March 9, 2009 | K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | EJI | Substantially Equivalent | Miltex, Inc. | accessdata.fda.gov |
| January 12, 2009 | K083162 | STINGRAY ELECTROSURGICAL FORCEPS | GEI | Substantially Equivalent | Stingray Surgical Products, Inc. | accessdata.fda.gov |
| November 21, 2008 | K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | HDC | Substantially Equivalent | J. Jamner Surgical Instruments, Inc. | accessdata.fda.gov |
| August 8, 2008 | K081651 | INSTRUMED RONGEUR | HAE | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071771 | INSTRUMED RETRACTORS | GZT | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| July 19, 2006 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| June 30, 2006 | K061271 | ERCH ARCH BAR, MODEL 38-690-00 | DYX | Substantially Equivalent | KLS-Martin L.P. | accessdata.fda.gov |
| April 16, 2004 | K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | GEI | Substantially Equivalent | Instrumed International, Inc. | accessdata.fda.gov |
| January 22, 2004 | K033403 | T.S. MEDICAL CIRCUMCISION CLAMP | HFX | Substantially Equivalent | T.S. Medical | accessdata.fda.gov |
| March 25, 2003 | K030665 | BONE WIRE | HTY | Substantially Equivalent | Stork Instrumente GmbH | accessdata.fda.gov |
| March 1, 2001 | K003717 | INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF | GEI | Substantially Equivalent | Tekno Medical Optik-Chirurgie GmbH & Co. | accessdata.fda.gov |
| June 23, 2000 | K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP | GAW | Substantially Equivalent for Some Indications | Cp Medical | accessdata.fda.gov |
| April 24, 2000 | K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | FHN | Substantially Equivalent | Erchinger Medizintecnik | accessdata.fda.gov |
| May 10, 1999 | K990671 | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | HOZ | Substantially Equivalent | Hurricane Medical | accessdata.fda.gov |
| September 30, 1998 | K982620 | MEDIVISION CYSTOSCOPE | FAJ | Substantially Equivalent | Medivision Scope Service Center, Inc. | accessdata.fda.gov |
| June 24, 1998 | K974595 | CUSHING BAYONET, INSULATED BIPOLAR FORCEP | HTD | Substantially Equivalent | Titan Mfg., Inc. | accessdata.fda.gov |
| June 24, 1998 | K974594 | SEMKIN BIPOLAR FORCEP | HTD | Substantially Equivalent | Titan Mfg., Inc. | accessdata.fda.gov |
| June 24, 1998 | K974593 | SEMKIN INSULATED BIPOLAR FORCEP | HTD | Substantially Equivalent | Titan Mfg., Inc. | accessdata.fda.gov |
| May 21, 1998 | K970968 | BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS | HET | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| April 21, 1998 | K974382 | ACKERMANN SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | Ackermann Instrumente GmbH | accessdata.fda.gov |
| March 19, 1998 | K974793 | ELMED ESU 120 M/M DIGITAL | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| October 3, 1997 | K972661 | EYE SPHERE, CONFORMERS | HPZ | Substantially Equivalent | Gulden Ophthalmics | accessdata.fda.gov |
| September 19, 1997 | K972901 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| August 14, 1997 | K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | GEI | Substantially Equivalent | Tecno Instruments (Usa), Inc. | accessdata.fda.gov |
| July 31, 1997 | K971996 | MEDIVISION ARTHROSCOP | HRX | Substantially Equivalent | Medivision Scope Service Center, Inc. | accessdata.fda.gov |
| March 7, 1997 | K962545 | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE | KCT | Substantially Equivalent | Sterilization Cassette Systems, Inc. | accessdata.fda.gov |
| February 12, 1997 | K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. | GAM | Substantially Equivalent | Lukens Medical Corp. | accessdata.fda.gov |
| January 23, 1997 | K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | GZT | Substantially Equivalent | V. Mueller Neuro/Spine | accessdata.fda.gov |
| January 17, 1997 | K962075 | HSW GMBH ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| July 1, 1996 | K960347 | SAFETY TROCER WITH SPRINGLOADED OBDURATOR | HET | Substantially Equivalent | Spiess Design, Inc. | accessdata.fda.gov |
| October 18, 1995 | K953889 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| May 8, 1995 | K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE | HKY | Substantially Equivalent | Rudolf Riester GmbH & Co. KG | accessdata.fda.gov |
| November 15, 1994 | K926517 | ELMED LBC 50-P | HIN | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| May 2, 1994 | K932938 | ELMED ESU 300 M/M AND DIGITAL | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| April 1, 1994 | K933174 | GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE | FAS | Substantially Equivalent | Greenwald Surgical Co., Inc. | accessdata.fda.gov |
| April 1, 1994 | K933173 | GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE | FAS | Substantially Equivalent | Greenwald Surgical Co., Inc. | accessdata.fda.gov |
| January 7, 1994 | K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | GAP | Substantially Equivalent | Surgical Specialties, Inc. | accessdata.fda.gov |
| May 17, 1993 | K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| November 5, 1992 | K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL | GEI | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
| May 2, 1991 | K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | GEI | Substantially Equivalent | Mentor O & O, Inc. | accessdata.fda.gov |
| October 25, 1990 | K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE | GAR | Substantially Equivalent | Look, Inc. | accessdata.fda.gov |
| September 20, 1990 | K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | HBG | Substantially Equivalent | Ruggles Corp. | accessdata.fda.gov |
| August 7, 1989 | K890765 | STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| August 7, 1989 | K890755 | SEALING TAPE, STERILIZATION INDICATOR; STEAM | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| July 25, 1989 | K894303 | MEDSCOPE 4MM ARTHROSCOPE | HRX | Substantially Equivalent | Medscope Corp. | accessdata.fda.gov |
| April 23, 1984 | K832589 | ELMED WMC 10 AND BC 50 M/M | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov | |
| April 23, 1981 | K810529 | DIRECT WRITING VECTORCARDIOGRAPH | DYC | Substantially Equivalent | Elmed, Inc. | accessdata.fda.gov |
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Updated March 22, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.