GYNECARE TVT ABBREVO CONTINENCE SYSTEM— 510(k) K100936
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K100936 for GYNECARE TVT ABBREVO CONTINENCE SYSTEM, Substantially Equivalent on 2010-07-01. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code OTN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
Recent devices under product code OTN
view all- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K222293 — ArcSP Suprapubic Sling System
- K222468 — ArcTO Transobturator Sling System
- K211975 — Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
- K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
More clearances from ETHICON, Inc.
view all- K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- 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
Adverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
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.