The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Uhi-3 High Flow Insufflation Unit.
| Device ID | K014166 |
| 510k Number | K014166 |
| Device Name: | UHI-3 HIGH FLOW INSUFFLATION UNIT |
| Classification | Insufflator, Laparoscopic |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-19 |
| Decision Date | 2002-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170196102 | K014166 | 000 |
| 04953170061325 | K014166 | 000 |
| 14953170061674 | K014166 | 000 |
| 04953170140280 | K014166 | 000 |
| 04953170140297 | K014166 | 000 |
| 04953170140310 | K014166 | 000 |
| 04953170140365 | K014166 | 000 |
| 04953170140389 | K014166 | 000 |
| 04953170196096 | K014166 | 000 |
| 04953170061318 | K014166 | 000 |