FISCH DRILL SYSTEM— 510(k) K792159
Substantially EquivalentJedmed Instrument Co.
FDA 510(k) clearance K792159 for FISCH DRILL SYSTEM, Substantially Equivalent on 1979-11-27. Applicant: Jedmed Instrument Co.. Device class: 2.
Clearance details
- Applicant
- Jedmed Instrument Co.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code ERL
view allMore clearances from Jedmed Instrument Co.
view allAdverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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 K792159
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 K792159.
Data sourced from openFDA. This site is unofficial and independent of the FDA.