The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Endochoice Grasping Insulated And Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping Insulated And Rat Tooth Forceps.
| Device ID | K101298 |
| 510k Number | K101298 |
| Device Name: | ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | ENDOCHOICE, INC. 11800 WILLIS RD SUITE 100 Alpharetta, GA 30009 |
| Contact | Theron Gober |
| Correspondent | Theron Gober ENDOCHOICE, INC. 11800 WILLIS RD SUITE 100 Alpharetta, GA 30009 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-10 |
| Decision Date | 2010-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16948318968807 | K101298 | 000 |
| 16948318903983 | K101298 | 000 |
| 16948318903938 | K101298 | 000 |
| 16948318903907 | K101298 | 000 |
| 16948318903822 | K101298 | 000 |