CODMAN SUCTION PUNCH-PRODUCT CODES— 510(k) K842774
Substantially EquivalentCodman & Shurtleff, Inc.
FDA 510(k) clearance K842774 for CODMAN SUCTION PUNCH-PRODUCT CODES, Substantially Equivalent on 1984-07-27. Applicant: Codman & Shurtleff, Inc.. Device class: 1.
Clearance details
- Applicant
- Codman & Shurtleff, Inc.
- Product code
- Code HTZ
- 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
- Walker, MI, US
Recent devices under product code HTZ
view allMore clearances from Codman & Shurtleff, Inc.
view all- K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
- K191237 — CERENOVUS Large Bore Catheter
- K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
- K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
Adverse events under product code HTZ
product code HTZ- Malfunction
- 1,133
- Total
- 1,133
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.