The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Endoscopic Trocar.
| Device ID | K052299 |
| 510k Number | K052299 |
| Device Name: | REPROCESSED ENDOSCOPIC TROCAR |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Thomas A Dold |
| Correspondent | Thomas A Dold 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 | 2005-08-24 |
| Decision Date | 2006-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888551043028 | K052299 | 000 |
| 10888551018791 | K052299 | 000 |
| 10888551018784 | K052299 | 000 |
| 20888551043103 | K052299 | 000 |
| 10888551018760 | K052299 | 000 |
| 20888551043110 | K052299 | 000 |
| 10888551010948 | K052299 | 000 |
| 20888551043097 | K052299 | 000 |
| 20888551043080 | K052299 | 000 |
| 10888551018807 | K052299 | 000 |
| 10888551018814 | K052299 | 000 |
| 20888551043059 | K052299 | 000 |
| 20888551043035 | K052299 | 000 |
| 20888551043042 | K052299 | 000 |
| 20888551043066 | K052299 | 000 |
| 10888551018852 | K052299 | 000 |
| 20888551043127 | K052299 | 000 |
| 20888551043134 | K052299 | 000 |
| 10888551018821 | K052299 | 000 |
| 10888551010917 | K052299 | 000 |