X-Tack Endoscopic HeliX Tacking System— 510(k) K201808
Substantially EquivalentApollo Endosurgery, Inc.
FDA 510(k) clearance K201808 for X-Tack Endoscopic HeliX Tacking System, Substantially Equivalent on 2020-12-15. Applicant: Apollo Endosurgery, Inc.. Device class: 2.
Clearance details
- Applicant
- Apollo Endosurgery, Inc.
- Product code
- Code PKL
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code PKL
view allMore clearances from Apollo Endosurgery, Inc.
view all- K232544 — Apollo ESG NXT System, Apollo REVISE NXT System
- K231553 — OverStitch NXT Endoscopic Suturing System
- DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
- K210266 — OverStitch Sx Endoscopic Suturing System
- K171886 — OverStitch SX Endoscopic Suturing System (ESS)
Adverse events under product code PKL
product code PKL- Death
- 9
- Injury
- 489
- Malfunction
- 4,698
- Other
- 1
- Total
- 5,197
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 K201808
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 K201808.
Data sourced from openFDA. This site is unofficial and independent of the FDA.