The following data is part of a premarket notification filed by Apollo Endosurgery with the FDA for Overstitch Endoscopic Suturing System And Accessories.
Device ID | K181141 |
510k Number | K181141 |
Device Name: | OverStitch Endoscopic Suturing System And Accessories |
Classification | Endoscopic Tissue Approximation Device |
Applicant | Apollo Endosurgery 1120 S. Capital Of Texas Hwy Ste. 300 Austin, TX 78746 |
Contact | Maritza Ward |
Correspondent | Maritza Ward Apollo Endosurgery 1120 S. Capital Of Texas Hwy Ste. 300 Austin, TX 78746 |
Product Code | OCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-01 |
Decision Date | 2018-06-27 |
Summary: | summary |