GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES— 510(k) K971781
Substantially EquivalentWilson Greatbatch Technologies, Inc.
FDA 510(k) clearance K971781 for GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES, Substantially Equivalent on 1997-11-21. Applicant: Wilson Greatbatch Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson Greatbatch Technologies, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clarence, NY, US
Recent devices under product code HRX
view allMore clearances from Wilson Greatbatch Technologies, Inc.
view all- K971374 — GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
- K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
- K972280 — GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
- K970619 — GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
- K971375 — GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.