POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)— 510(k) K002190
Substantially Equivalent for Some IndicationsCp Medical
FDA 510(k) clearance K002190 for POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP), Substantially Equivalent for Some Indications on 2000-08-10. Applicant: Cp Medical. Device class: 2.
Clearance details
- Applicant
- Cp Medical
- Product code
- Code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Portland, OR, US
Recent devices under product code GAM
view all- 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
- K253620 — TroClose 1200
More clearances from Cp Medical
view allAdverse 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 →
Recalls naming K002190
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002190.
Data sourced from openFDA. This site is unofficial and independent of the FDA.