7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application— 510(k) K192945
Substantially Equivalent7D Surgical, Inc.
FDA 510(k) clearance K192945 for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, Substantially Equivalent on 2019-11-27. Applicant: 7D Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- 7D Surgical, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Toronto, CA
Recent devices under product code HAW
view allMore clearances from 7D Surgical, Inc.
view all- K210457 — 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key
- K210555 — 7D Surgical System - Drill Guide
- K201966 — 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array
- K192140 — 7D Surgical System
- K183276 — 7D Surgical System
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
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.