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 |