The following data is part of a premarket notification filed by Covidien with the FDA for Truclear Elite Hysteroscope.
| Device ID | K180496 |
| 510k Number | K180496 |
| Device Name: | TruClear Elite Hysteroscope |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Covidien 60 Middletown Ave. North Haven, CT 06473 |
| Contact | Gail Yaeker-daunis |
| Correspondent | Gail Yaeker-daunis Covidien 60 Middletown Ave. North Haven, CT 06473 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-26 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521767744 | K180496 | 000 |
| 10884521767737 | K180496 | 000 |
| 20884521750200 | K180496 | 000 |
| 10884521746657 | K180496 | 000 |
| 10884521746640 | K180496 | 000 |
| 10884521746633 | K180496 | 000 |
| 10884521746626 | K180496 | 000 |