The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Endoscopic Trocar.
| Device ID | K012578 |
| 510k Number | K012578 |
| Device Name: | REPROCESSED ENDOSCOPIC TROCAR |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE N., SUITE 100 Maple Grove, MN 55369 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker STERILMED, INC. 11400 73RD AVE N., SUITE 100 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 | 2001-08-09 |
| Decision Date | 2001-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888551044308 | K012578 | 000 |
| 10888551013185 | K012578 | 000 |
| 10888551013178 | K012578 | 000 |
| 10888551013161 | K012578 | 000 |
| 10888551013154 | K012578 | 000 |
| 10888551013147 | K012578 | 000 |
| 10888551013130 | K012578 | 000 |
| 10888551013086 | K012578 | 000 |
| 10888551013062 | K012578 | 000 |
| 10888551012980 | K012578 | 000 |
| 10888551012973 | K012578 | 000 |
| 10888551013192 | K012578 | 000 |
| 10888551013208 | K012578 | 000 |
| 10888551013215 | K012578 | 000 |
| 20888551044292 | K012578 | 000 |
| 20888551044285 | K012578 | 000 |
| 20888551044278 | K012578 | 000 |
| 20888551044261 | K012578 | 000 |
| 20888551044254 | K012578 | 000 |
| 20888551044247 | K012578 | 000 |
| 20888551044230 | K012578 | 000 |
| 10888551013246 | K012578 | 000 |
| 10888551013239 | K012578 | 000 |
| 10888551013222 | K012578 | 000 |
| 10888551010016 | K012578 | 000 |