ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)— 510(k) K080412
Substantially EquivalentShanghai Pudong Jinhuan Medical Products Co., Ltd.
FDA 510(k) clearance K080412 for ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED), Substantially Equivalent on 2008-09-04. Applicant: Shanghai Pudong Jinhuan Medical Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai Pudong Jinhuan Medical Products Co., Ltd.
- Product code
- Product code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Mirada, CA, US
Recent devices under product code GAM
view all- K263073 — Fast Absorbing PGLA
- K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- K253530 — Trexon Monofilament Synthetic Absorbable Suture
- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.