The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Endoscopic Trocar.
| Device ID | K043592 |
| 510k Number | K043592 |
| Device Name: | REPROCESSED ENDOSCOPIC TROCAR |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Bruce R Lester |
| Correspondent | Bruce R Lester STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-29 |
| Decision Date | 2005-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888551044223 | K043592 | 000 |
| 10888551013055 | K043592 | 000 |
| 10888551013048 | K043592 | 000 |
| 10888551012522 | K043592 | 000 |
| 10888551010887 | K043592 | 000 |
| 10888551010870 | K043592 | 000 |
| 10888551010863 | K043592 | 000 |
| 10888551010856 | K043592 | 000 |
| 10888551010047 | K043592 | 000 |
| 10888551010030 | K043592 | 000 |
| 10888551010023 | K043592 | 000 |
| 10888551010009 | K043592 | 000 |
| 10888551009997 | K043592 | 000 |
| 10888551009980 | K043592 | 000 |
| 10888551009973 | K043592 | 000 |
| 10888551009966 | K043592 | 000 |
| 10888551013079 | K043592 | 000 |
| 10888551013093 | K043592 | 000 |
| 10888551013109 | K043592 | 000 |
| 20888551044216 | K043592 | 000 |
| 20888551044209 | K043592 | 000 |
| 20888551043141 | K043592 | 000 |
| 20888551042717 | K043592 | 000 |
| 10888551013413 | K043592 | 000 |
| 10888551013406 | K043592 | 000 |
| 10888551013390 | K043592 | 000 |
| 10888551013383 | K043592 | 000 |
| 10888551013376 | K043592 | 000 |
| 10888551013369 | K043592 | 000 |
| 10888551013352 | K043592 | 000 |
| 10888551013345 | K043592 | 000 |
| 10888551013253 | K043592 | 000 |
| 10888551013123 | K043592 | 000 |
| 10888551013116 | K043592 | 000 |
| 10888551009959 | K043592 | 000 |