GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE— 510(k) K971377
Substantially EquivalentWilson Greatbatch Technologies, Inc.
FDA 510(k) clearance K971377 for GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE, Substantially Equivalent on 1998-04-30. Applicant: Wilson Greatbatch Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Wilson Greatbatch Technologies, Inc.
- Product code
- Code CCW
- Device class
- Class 1
- Regulation
- 21 CFR 868.5540
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clarence, NY, US
Recent devices under product code CCW
view allMore clearances from Wilson Greatbatch Technologies, Inc.
view all- K971374 — GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
- K972280 — GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
- K971781 — GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
- K970619 — GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
- K971375 — GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
Adverse events under product code CCW
product code CCW- Death
- 31
- Injury
- 136
- Malfunction
- 3,703
- Other
- 1
- Total
- 3,871
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.