CUTALON NYLON POLYAMIDE SURGICAL SUTURE— 510(k) K981322
Substantially EquivalentGenzyme Surgical Product (Genzyme Biosurgery)
FDA 510(k) clearance K981322 for CUTALON NYLON POLYAMIDE SURGICAL SUTURE, Substantially Equivalent on 1998-07-07. Applicant: Genzyme Surgical Product (Genzyme Biosurgery). Device class: 2.
Clearance details
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Product code
- Code GAR
- Device class
- Class 2
- Regulation
- 21 CFR 878.5020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fall River, MA, US
Recent devices under product code GAR
view allMore clearances from Genzyme Surgical Product (Genzyme Biosurgery)
view all- K001440 — NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
- K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
- K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K991416 — ENDOSCOPIC CAMERA
- K991191 — BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
Adverse events under product code GAR
product code GAR- Injury
- 422
- Malfunction
- 3,386
- Other
- 4
- Total
- 3,812
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.