The following data is part of a premarket notification filed by Egon Faulhaber Surgical Instruments Pinzetten with the FDA for Non Stick Bipolar Forceps Model 07/xxx, Bipolar Forceps Model 08/xxx, Monopolar Forceps Model 09/xxx.
| Device ID | K101080 |
| 510k Number | K101080 |
| Device Name: | NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN UNTERER WINKEL 3 Wurmlingen, DE D-78573 |
| Contact | Harald Jung |
| Correspondent | Harald Jung EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN UNTERER WINKEL 3 Wurmlingen, DE D-78573 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2010-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B09927009550 | K101080 | 000 |
| B0992700846NS0 | K101080 | 000 |
| B0992700842NS0 | K101080 | 000 |
| B0992700840NS0 | K101080 | 000 |
| B0992700839NS0 | K101080 | 000 |
| B0992700835NS0 | K101080 | 000 |
| B09927008140 | K101080 | 000 |
| B09927008120 | K101080 | 000 |
| B0992700802NS0 | K101080 | 000 |
| B0992700800NS0 | K101080 | 000 |
| B0992700560NS0 | K101080 | 000 |
| B0992700558NS0 | K101080 | 000 |
| B0992700556NS0 | K101080 | 000 |
| B0992700550NS0 | K101080 | 000 |
| 04250676735348 | K101080 | 000 |
| B0992700850NS0 | K101080 | 000 |
| B0992700854NS0 | K101080 | 000 |
| B0992700856NS0 | K101080 | 000 |
| B09927009510 | K101080 | 000 |
| B09927009470 | K101080 | 000 |
| B09927009450 | K101080 | 000 |
| B09927009420 | K101080 | 000 |
| B09927009310 | K101080 | 000 |
| B09927009300 | K101080 | 000 |
| B09927009250 | K101080 | 000 |
| B09927009240 | K101080 | 000 |
| B09927009220 | K101080 | 000 |
| B09927009080 | K101080 | 000 |
| B09927009050 | K101080 | 000 |
| B099270089150 | K101080 | 000 |
| B0992700890NS0 | K101080 | 000 |
| B09927008800 | K101080 | 000 |
| 04250676718488 | K101080 | 000 |
| 04250381887905 | K101080 | 000 |
| 00192896100398 | K101080 | 000 |
| 00841036020774 | K101080 | 000 |
| 04250381887882 | K101080 | 000 |
| 00192896109223 | K101080 | 000 |
| 00192896112162 | K101080 | 000 |
| 00192896113497 | K101080 | 000 |
| 04250381889794 | K101080 | 000 |
| 04250676735966 | K101080 | 000 |
| 04250676735935 | K101080 | 000 |
| 04250676735904 | K101080 | 000 |
| 04250381888001 | K101080 | 000 |
| 04250381887868 | K101080 | 000 |
| 00192896114999 | K101080 | 000 |
| 00192896117143 | K101080 | 000 |
| 04250381825891 | K101080 | 000 |
| 04250381858882 | K101080 | 000 |
| 04250381887721 | K101080 | 000 |
| 00425038188788 | K101080 | 000 |
| 04250676718563 | K101080 | 000 |
| 04250676718532 | K101080 | 000 |
| 04250676718471 | K101080 | 000 |
| 04250676710055 | K101080 | 000 |
| 04250676710048 | K101080 | 000 |
| 04250381894354 | K101080 | 000 |
| 04250381892800 | K101080 | 000 |
| 04250381892794 | K101080 | 000 |
| 04250381892787 | K101080 | 000 |
| 04250381890431 | K101080 | 000 |
| 04250381889787 | K101080 | 000 |
| 04250381888162 | K101080 | 000 |
| 04250381887899 | K101080 | 000 |
| 00192896117136 | K101080 | 000 |
| 00192896089525 | K101080 | 000 |
| B0992700980NS0 | K101080 | 000 |
| B09927009800 | K101080 | 000 |
| B0992700968NS0 | K101080 | 000 |
| B09927009680 | K101080 | 000 |
| B09927009670 | K101080 | 000 |
| B09927009650 | K101080 | 000 |
| B09927009630 | K101080 | 000 |
| B09927009610 | K101080 | 000 |
| B09927009600 | K101080 | 000 |
| B09927009590 | K101080 | 000 |
| B0992700941NS0 | K101080 | 000 |
| 00192896006522 | K101080 | 000 |
| B0992700924NS0 | K101080 | 000 |
| B0992700908NS0 | K101080 | 000 |
| B09927009830 | K101080 | 000 |
| B09927009870 | K101080 | 000 |
| B09927009900 | K101080 | 000 |
| B09927009060 | K101080 | 000 |
| B09927009880 | K101080 | 000 |
| 00192896010833 | K101080 | 000 |
| 00192896010826 | K101080 | 000 |
| B09927009840 | K101080 | 000 |
| 00192896010802 | K101080 | 000 |
| B09927009200 | K101080 | 000 |
| B09927009180 | K101080 | 000 |
| B09927009150 | K101080 | 000 |
| B0992700902F0 | K101080 | 000 |
| B09927008900 | K101080 | 000 |
| 00192896009783 | K101080 | 000 |
| B0992700995NS0 | K101080 | 000 |
| B09927009950 | K101080 | 000 |
| B0992700903NS0 | K101080 | 000 |
| B09927009020 | K101080 | 000 |
| B0992700830NS0 | K101080 | 000 |
| B09927008190 | K101080 | 000 |
| B09927008170 | K101080 | 000 |
| B09927008150 | K101080 | 000 |
| B09927008100 | K101080 | 000 |
| B0992700554NS0 | K101080 | 000 |
| B0992700552NS0 | K101080 | 000 |
| B0991627700 | K101080 | 000 |
| B0991627600 | K101080 | 000 |
| B0991627100 | K101080 | 000 |
| B0991627000 | K101080 | 000 |
| 04250381892572 | K101080 | 000 |
| 04250381887998 | K101080 | 000 |
| 04250381887950 | K101080 | 000 |
| B0992700837NS0 | K101080 | 000 |
| B0992700844NS0 | K101080 | 000 |
| B0992700852NS0 | K101080 | 000 |
| B0992700900NS0 | K101080 | 000 |
| B09927009000 | K101080 | 000 |
| B0992700891NS0 | K101080 | 000 |
| B09927008910 | K101080 | 000 |
| B09927008870 | K101080 | 000 |
| B0992700881NS0 | K101080 | 000 |
| B099270088150 | K101080 | 000 |
| B09927008810 | K101080 | 000 |
| B0992700880NS0 | K101080 | 000 |
| B0992700864NS0 | K101080 | 000 |
| B0992700862NS0 | K101080 | 000 |
| B09927008610 | K101080 | 000 |
| B0992700859NS0 | K101080 | 000 |
| B09927008591NS0 | K101080 | 000 |
| 04250381887752 | K101080 | 000 |