Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system

Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes.
The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce the system into the US market.
The newly cleared accessory makes the system, which was previously limited in compatibility to a select number of dual-channel endoscopes, compatible with a wider range of endoscopes, Apollo said in a press release.
Earlier this month, Apollo Endosurgery said it closed a $23.7 million round of financing.
The post Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system appeared first on MassDevice.

Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Surgical Apollo Endosurgery Source Type: news