MASTERPIECES(TM)/MICRO/MINI SYSTEMS— 510(k) K913289
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K913289 for MASTERPIECES(TM)/MICRO/MINI SYSTEMS, Substantially Equivalent on 1991-09-05. Applicant: Storz Instrument Co.. Device class: 2.
Clearance details
- Applicant
- Storz Instrument Co.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code HRS
view allMore clearances from Storz Instrument Co.
view all- K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
- K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
- K972664 — STORZ MILLENNIUM VISCOUS FLUID SYSTEM
- K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
- K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.