SILK SUTURE— 510(k) K982853
Substantially Equivalent for Some IndicationsDavis & Geck, Inc.
FDA 510(k) clearance K982853 for SILK SUTURE, Substantially Equivalent for Some Indications on 1999-04-30. Applicant: Davis & Geck, Inc.. Device class: 2.
Clearance details
- Applicant
- Davis & Geck, Inc.
- Product code
- Code GAP
- Device class
- Class 2
- Regulation
- 21 CFR 878.5030
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Hazlewood, MO, US
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- K980610 — DEXON RAPID (DEXON R)
- K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
- K973409 — KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
Adverse events under product code GAP
product code GAP- Death
- 3
- Injury
- 491
- Malfunction
- 2,253
- Total
- 2,747
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.