The following data is part of a premarket notification filed by Sims Portex Ltd. with the FDA for Suresample-wallace Endometrial Sampler, Endo 26.
| Device ID | K001555 |
| 510k Number | K001555 |
| Device Name: | SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | SIMS PORTEX LTD. HYTHE Hythe, Kent, GB Ct 21 6jl |
| Contact | Steven M Ogilvie |
| Correspondent | Steven M Ogilvie SIMS PORTEX LTD. HYTHE Hythe, Kent, GB Ct 21 6jl |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-18 |
| Decision Date | 2000-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| GYNX31214 | K001555 | 000 |
| GYNX31203 | K001555 | 000 |
| GYNX31151 | K001555 | 000 |
| GYNX31051 | K001555 | 000 |
| GYNX31350 | K001555 | 000 |
| GYNX31300 | K001555 | 000 |