The following data is part of a premarket notification filed by Faulhaber Pinzetten Ohg with the FDA for Single-use Non-stick Bipolar Forceps Bayonet, Single-use Non-stick Bipolar Irrigating Forceps, Single Use Non-stick Bipolar Suction Forceps.
| Device ID | K182773 |
| 510k Number | K182773 |
| Device Name: | Single-Use Non-Stick Bipolar Forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating Forceps, Single Use Non-Stick Bipolar Suction Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Faulhaber Pinzetten OHG Daimlerstr. 1 Frittlingen, DE 78665 |
| Contact | Dorothea Faulhaber |
| Correspondent | Dorothea Faulhaber Faulhaber Pinzetten OHG Daimlerstr. 1 Frittlingen, DE 78665 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2019-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B419350801080 | K182773 | 000 |
| 00850063380089 | K182773 | 000 |
| 00850063380072 | K182773 | 000 |
| 00850063380065 | K182773 | 000 |
| 00850063380058 | K182773 | 000 |
| 00850063380041 | K182773 | 000 |
| 00850063380034 | K182773 | 000 |
| 00850063380027 | K182773 | 000 |
| 00850063380010 | K182773 | 000 |
| 00850063380003 | K182773 | 000 |
| 00850063380096 | K182773 | 000 |
| 00850063380102 | K182773 | 000 |
| 00850063380195 | K182773 | 000 |
| 00850063380188 | K182773 | 000 |
| 00850063380171 | K182773 | 000 |
| 00850063380164 | K182773 | 000 |
| 00850063380157 | K182773 | 000 |
| 00850063380140 | K182773 | 000 |
| 00850063380133 | K182773 | 000 |
| 00850063380126 | K182773 | 000 |
| 00850063380119 | K182773 | 000 |
| B4193683010 | K182773 | 000 |