Standard Trocar
Laparoscope, General & Plastic Surgery
Standard Bariatrics
The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Standard Trocar.
Pre-market Notification Details
| Device ID | K200517 |
| 510k Number | K200517 |
| Device Name: | Standard Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Contact | Alison Sathe |
| Correspondent | Alison Sathe Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-04-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851677007048 | K200517 | 000 |
Trademark Results [Standard Trocar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STANDARD TROCAR 88878000 not registered Live/Pending |
Standard Bariatrics, Inc. 2020-04-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.