INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE— 510(k) K990493
Substantially EquivalentInnerdyne, Inc.
FDA 510(k) clearance K990493 for INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE, Substantially Equivalent on 1999-05-18. Applicant: Innerdyne, Inc.. Device class: 2.
Clearance details
- Applicant
- Innerdyne, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code GCJ
view allMore clearances from Innerdyne, Inc.
view all- K992668 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
- K990854 — INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
- K982417 — INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
- K980578 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
- K972684 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.