7D Surgical System Cranial Application— 510(k) K181041
Substantially Equivalent7D Surgical, Inc.
FDA 510(k) clearance K181041 for 7D Surgical System Cranial Application, Substantially Equivalent on 2018-08-08. 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
- Traditional
- 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
- K192945 — 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
- K192140 — 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.