OverStitch NXT Endoscopic Suturing System— 510(k) K231553
Substantially EquivalentApollo Endosurgery, Inc.
FDA 510(k) clearance K231553 for OverStitch NXT Endoscopic Suturing System, Substantially Equivalent on 2023-06-29. Applicant: Apollo Endosurgery, Inc.. Device class: 2.
Clearance details
- Applicant
- Apollo Endosurgery, Inc.
- Product code
- Code OCW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Recent devices under product code OCW
view allMore clearances from Apollo Endosurgery, Inc.
view all- K232544 — Apollo ESG NXT System, Apollo REVISE NXT System
- DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
- K210266 — OverStitch Sx Endoscopic Suturing System
- K201808 — X-Tack Endoscopic HeliX Tacking System
- K171886 — OverStitch SX Endoscopic Suturing System (ESS)
Adverse events under product code OCW
product code OCW- Death
- 6
- Injury
- 443
- Malfunction
- 1,023
- Other
- 2
- Total
- 1,474
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.