The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Universal Cannula Seal (5-12 Mm).
Device ID | K181395 |
510k Number | K181395 |
Device Name: | Universal Cannula Seal (5-12 Mm) |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
Contact | Cheryl Wu |
Correspondent | Cheryl Wu Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-29 |
Decision Date | 2018-07-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30886874116402 | K181395 | 000 |