CHURCHILL MEDICAL SYSTEMS STOPCOCK— 510(k) K012157
Substantially EquivalentChurchill Medical Systems, Inc.
FDA 510(k) clearance K012157 for CHURCHILL MEDICAL SYSTEMS STOPCOCK, Substantially Equivalent on 2001-09-11. Applicant: Churchill Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Churchill Medical Systems, Inc.
- Product code
- Code FMG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dover, NH, US
Recent devices under product code FMG
view allMore clearances from Churchill Medical Systems, Inc.
view all- K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
- K021395 — MODIFICATION TO 30 EXTENSION SET
- K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
- K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
- K013950 — VENTED VIAL ACCESS DEVICE
Adverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
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 →
Recalls naming K012157
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012157.
Data sourced from openFDA. This site is unofficial and independent of the FDA.