PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP— 510(k) K001299
Substantially Equivalent for Some IndicationsCp Medical
FDA 510(k) clearance K001299 for PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent for Some Indications on 2000-06-23. Applicant: Cp Medical. Device class: 2.
Clearance details
- Applicant
- Cp Medical
- Product code
- Code GAL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4830
- 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 GAL
view allMore clearances from Cp Medical
view allAdverse events under product code GAL
product code GAL- Malfunction
- 681
- Other
- 1
- Total
- 682
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 K001299
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 K001299.
Data sourced from openFDA. This site is unofficial and independent of the FDA.