MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE— 510(k) K030212
Substantially EquivalentGenzyme Biosurgery
FDA 510(k) clearance K030212 for MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE, Substantially Equivalent on 2003-03-27. Applicant: Genzyme Biosurgery. Device class: 2.
Clearance details
- Applicant
- Genzyme Biosurgery
- Product code
- Code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fall River, MA, US
Recent devices under product code NEW
view all- K253879 — MONOFIX PDO
- K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
- K252171 — Barbed PDO Suture
- K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
More clearances from Genzyme Biosurgery
view allAdverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
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 K030212
K-number listed on FDA's recall record- Z-1509-2014 — Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
- Z-1534-2014 — CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030212.
Data sourced from openFDA. This site is unofficial and independent of the FDA.