OverStitch Endoscopic Suturing System and Accessories— 510(k) K181141
Substantially EquivalentApollo Endosurgery
FDA 510(k) clearance K181141 for OverStitch Endoscopic Suturing System and Accessories, Substantially Equivalent on 2018-06-27. Applicant: Apollo Endosurgery. Device class: 2.
Clearance details
- Applicant
- Apollo Endosurgery
- 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
view allAdverse 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 →
Recalls naming K181141
K-number listed on FDA's recall record- Z-2961-2026 — OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Z-2962-2026 — Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181141.
Data sourced from openFDA. This site is unofficial and independent of the FDA.