The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Surgical Tissue Management System.
| Device ID | K111202 |
| 510k Number | K111202 |
| Device Name: | SURGICAL TISSUE MANAGEMENT SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy A Kluesner, M.s., Rac |
| Correspondent | Stacy A Kluesner, M.s., Rac OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | GEI |
| Subsequent Product Code | KNS |
| Subsequent Product Code | LFL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2012-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170370516 | K111202 | 000 |
| 14953170308458 | K111202 | 000 |
| 14953170308434 | K111202 | 000 |
| 14953170308410 | K111202 | 000 |
| 14953170308397 | K111202 | 000 |
| 14953170306751 | K111202 | 000 |
| 14953170306744 | K111202 | 000 |
| 04953170464980 | K111202 | 000 |
| 04953170464973 | K111202 | 000 |
| 14953170308472 | K111202 | 000 |
| 14953170308496 | K111202 | 000 |
| 14953170337571 | K111202 | 000 |
| 14953170337540 | K111202 | 000 |
| 14953170308731 | K111202 | 000 |
| 14953170308717 | K111202 | 000 |
| 14953170308694 | K111202 | 000 |
| 14953170308670 | K111202 | 000 |
| 14953170308656 | K111202 | 000 |
| 14953170308632 | K111202 | 000 |
| 04953170464935 | K111202 | 000 |