StitchKit— 510(k) K211792
Substantially EquivalentOrigami Surgical Inc .
FDA 510(k) clearance K211792 for StitchKit, Substantially Equivalent on 2021-07-16. Applicant: Origami Surgical Inc .. Device class: 2.
Clearance details
- Applicant
- Origami Surgical Inc .
- 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
- Special
- Location
- Madison, NJ, 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 Origami Surgical Inc .
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.