The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Gyrus Acmi Bicoag Hemostasis Probe.
| Device ID | K123319 |
| 510k Number | K123319 |
| Device Name: | GYRUS ACMI BICOAG HEMOSTASIS PROBE |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2012-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925039483 | K123319 | 000 |
| 00821925039476 | K123319 | 000 |
| 00821925039469 | K123319 | 000 |
| 00821925039452 | K123319 | 000 |