Data / Medical devices / France / Integra Microfrance SAS
Integra Microfrance SAS: FDA-registered device maker in SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, France, 6 510(k) clearances
Integra Microfrance SAS is registered with the FDA (registration 9680837) in SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, France. It lists 84 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680837
- FEI number
- 3003249645
- Address
- Le Pavillon, SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, France, 03160
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 24, 1981
- Registered through
- 2026
- Brand names listed
- 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710, 33-52;33-53;33-54;33-55;33-57, 4-110;4-111;4-112;4-112B;4-115;4-115C;4-120;4-121;4-122;4-123;4-125;4-310;4-311;4-312;4-312B;4-315;4-315C;4-320;4-321, 4-322;4-323;4-325;4610;4611;4615, 5-700;5-702;5801;5803;5804, Acclarent, Arkis Galea Elevator, Arkis Subcutaneous Guidewire and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Block, Cutting, Ent, Non-Sterile | NNR | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bone Particle Collector | MXP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Ear, Nose And Throat | EQJ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel, Middle-Ear | JYE | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Adenoid | KBJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Nasal | KAP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Die, Wire Bending, Ent, Non-Sterile | NNP | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Esophageal, Ent | KCF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Excavator, Ear | JYH | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Measuring | JYJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gouge, Nasal, Ent | KAQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Ear Speculum | JYK | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ear | JYO | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Laryngeal | JZY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Myringotomy | JYP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Nasal | KAS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Tonsil | KBQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Manufacturer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pick, Microsurgical Ear | JYT | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Press, Vein | JYW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe, Ent | KAK | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Punch, Ent | KTF | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Punch, Nasal | KAY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Ear | JYY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Rod, Measuring Ear | JYZ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ear | JZB | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Tonsil | KBZ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Ent | MMO | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tube, Laryngectomy | KAC | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tube, Tonsil Suction | KCB | 1 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| May 14, 2021 | K210942 | MicroFrance Monopolar and Bipolar Electrosurgical Instruments | GEI | Substantially Equivalent | Integra Microfrance | accessdata.fda.gov |
| January 20, 2012 | K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP | DXC | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| May 22, 2008 | K080257 | MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| March 17, 2008 | K073450 | SUTTER ELECTROSURGICAL CABLES | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| June 9, 2000 | K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | HET | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| December 21, 1999 | K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | GEI | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Punch, Nasal
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Tape, Measuring, Rulers And Calipers
- All makers of Knife, Ent
- All makers of Scissors, Ear
- All makers of Awl
Updated May 14, 2021. 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.