Capio SLIM Suture Capturing Device— 510(k) K172060
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K172060 for Capio SLIM Suture Capturing Device, Substantially Equivalent on 2017-11-03. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code PWI
- Device class
- Class 2
- Regulation
- 21 CFR 884.4910
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code PWI
view allMore clearances from Boston Scientific Corporation
view allRecalls naming K172060
K-number listed on FDA's recall record- Z-2451-2024 — Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
- Z-2452-2024 — Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
- Z-1616-2018 — Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
- Z-1617-2018 — Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172060.
Data sourced from openFDA. This site is unofficial and independent of the FDA.