The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Laparoscopic Suction Irrigator.
| Device ID | K934094 |
| 510k Number | K934094 |
| Device Name: | STRYKER LAPAROSCOPIC SUCTION IRRIGATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | STRYKER CORP. 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Charles Nelson |
| Correspondent | Charles Nelson STRYKER CORP. 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-23 |
| Decision Date | 1994-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327051711 | K934094 | 000 |
| 07613327051872 | K934094 | 000 |
| 07613327051889 | K934094 | 000 |
| 07613327051896 | K934094 | 000 |
| 07613327051902 | K934094 | 000 |
| 07613327051919 | K934094 | 000 |
| 07613327051926 | K934094 | 000 |
| 07613327051988 | K934094 | 000 |
| 07613327051995 | K934094 | 000 |
| 07613327051865 | K934094 | 000 |
| 07613327051858 | K934094 | 000 |
| 07613327051728 | K934094 | 000 |
| 07613327051735 | K934094 | 000 |
| 07613327051742 | K934094 | 000 |
| 07613327051759 | K934094 | 000 |
| 07613327051766 | K934094 | 000 |
| 07613327051773 | K934094 | 000 |
| 07613327051780 | K934094 | 000 |
| 07613327051797 | K934094 | 000 |
| 07613327052008 | K934094 | 000 |
| 07613327052015 | K934094 | 000 |
| 07613327052022 | K934094 | 000 |
| 37613327061278 | K934094 | 000 |
| 37613327061292 | K934094 | 000 |
| 37613327061308 | K934094 | 000 |
| 37613327061322 | K934094 | 000 |
| 37613327061346 | K934094 | 000 |
| 37613327061377 | K934094 | 000 |
| 37613327061384 | K934094 | 000 |
| 37613327061391 | K934094 | 000 |
| 37613327061254 | K934094 | 000 |
| 07613327052114 | K934094 | 000 |
| 07613327052039 | K934094 | 000 |
| 07613327052046 | K934094 | 000 |
| 07613327052053 | K934094 | 000 |
| 07613327052060 | K934094 | 000 |
| 07613327052077 | K934094 | 000 |
| 07613327052084 | K934094 | 000 |
| 07613327052091 | K934094 | 000 |
| 07613327052107 | K934094 | 000 |
| 37613327061452 | K934094 | 000 |