The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Endoscopic Trocars.
| Device ID | K121240 |
| 510k Number | K121240 |
| Device Name: | REPROCESSED ENDOSCOPIC TROCARS |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Jason Skramsted, Rac |
| Correspondent | Jason Skramsted, Rac 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 | 2012-04-24 |
| Decision Date | 2012-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551010849 | K121240 | 000 |
| 10888551010832 | K121240 | 000 |
| 10888551010825 | K121240 | 000 |
| 10888551010818 | K121240 | 000 |
| 10888551010801 | K121240 | 000 |
| 20888551043073 | K121240 | 000 |