SAPHLIFT— 510(k) K990062
Substantially EquivalentGenzyme Surgical Product (Genzyme Biosurgery)
FDA 510(k) clearance K990062 for SAPHLIFT, Substantially Equivalent on 1999-03-30. Applicant: Genzyme Surgical Product (Genzyme Biosurgery). Device class: 1.
Clearance details
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Product code
- Code MDM
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code MDM
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- 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 MDM
product code MDM- Injury
- 247
- Malfunction
- 1,516
- Total
- 1,763
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.