The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Bipolar Grasping Forceps Biq+.
| Device ID | K984417 |
| 510k Number | K984417 |
| Device Name: | BIPOLAR GRASPING FORCEPS BIQ+ |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-10 |
| Decision Date | 1999-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14042761001042 | K984417 | 000 |
| 04042761066983 | K984417 | 000 |
| 04042761063050 | K984417 | 000 |
| 04042761063067 | K984417 | 000 |
| 04042761063074 | K984417 | 000 |
| 04042761063081 | K984417 | 000 |
| 04042761063098 | K984417 | 000 |
| 04042761063104 | K984417 | 000 |
| 04042761066372 | K984417 | 000 |
| 04042761066389 | K984417 | 000 |
| 04042761066396 | K984417 | 000 |
| 04042761066976 | K984417 | 000 |
| 04042761066303 | K984417 | 000 |