PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.— 510(k) K022664
Substantially EquivalentArc Medical Supplies (Beijing) Co, Ltd.
FDA 510(k) clearance K022664 for PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P., Substantially Equivalent on 2002-09-10. Applicant: Arc Medical Supplies (Beijing) Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Arc Medical Supplies (Beijing) Co, Ltd.
- 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
- Clearance type
- Traditional
- Location
- New Berlin, WI, 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 Arc Medical Supplies (Beijing) Co, Ltd.
view all- K022666 — PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
- K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP
- K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
- K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
- K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP
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.