The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origin Blunt Tip Surgical Trocar.
| Device ID | K924011 |
| 510k Number | K924011 |
| Device Name: | ORIGIN BLUNT TIP SURGICAL TROCAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Albert K Chin |
| Correspondent | Albert K Chin ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-10 |
| Decision Date | 1993-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521539648 | K924011 | 000 |
| 20884521081090 | K924011 | 000 |
| 20884521081083 | K924011 | 000 |
| 20884521081076 | K924011 | 000 |
| 20884521552446 | K924011 | 000 |
| 20884521527383 | K924011 | 000 |
| 20884521080871 | K924011 | 000 |