The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Pk Lap Loop.
| Device ID | K142525 |
| 510k Number | K142525 |
| Device Name: | PK Lap Loop |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstrasse 61 Hamburg, DE 22045 |
| Contact | Graham A.l. Baillie |
| Correspondent | Graham A.l. Baillie Olympus Surgical Tech America, Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-08 |
| Decision Date | 2014-11-21 |
| Summary: | summary |