SurgiMend PRS Meshed, Revize-X— 510(k) K171357
Substantially EquivalentIntegra Lifesciences Corporation (Owner of Tei Biosciences)
FDA 510(k) clearance K171357 for SurgiMend PRS Meshed, Revize-X, Substantially Equivalent on 2017-06-07. Applicant: Integra Lifesciences Corporation (Owner of Tei Biosciences). Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Corporation (Owner of Tei Biosciences)
- Product code
- Code OXH
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boston, MA, US
Recent devices under product code OXH
view allRecalls naming K171357
K-number listed on FDA's recall record- Z-2070-2023 — SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
- Z-2084-2023 — Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171357.
Data sourced from openFDA. This site is unofficial and independent of the FDA.