AUTOSUTURE ENDOSCOPIC SUTURING DEVICE— 510(k) K934738
Substantially EquivalentUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K934738 for AUTOSUTURE ENDOSCOPIC SUTURING DEVICE, Substantially Equivalent on 1994-03-16. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.
Clearance details
- Applicant
- United States Surgical, A Division of Tyco Healthc
- 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
- Traditional
- Location
- Norwalk, CT, US
Recent devices under product code OCW
view allMore clearances from United States Surgical, A Division of Tyco Healthc
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 K934738
K-number listed on FDA's recall record- Z-2281-2026 — Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
- Z-2543-2017 — Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934738.
Data sourced from openFDA. This site is unofficial and independent of the FDA.