GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE— 510(k) K971375
Substantially EquivalentWilson Greatbatch Technologies, Inc.
FDA 510(k) clearance K971375 for GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE, Substantially Equivalent on 1997-10-31. Applicant: Wilson Greatbatch Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson Greatbatch Technologies, Inc.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clarence, NY, US
Recent devices under product code EOB
view all- K261544 — Hydro Irrigation System
- K254133 — ENTity USB Videoscope System
- K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K241731 — Outlook Surgical Versa One System (8900139)
More 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
- K971781 — GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
- K970619 — GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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.