MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES— 510(k) K003695
Substantially EquivalentMicro-Medical Devices, Inc.
FDA 510(k) clearance K003695 for MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES, Substantially Equivalent on 2001-02-14. Applicant: Micro-Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Micro-Medical Devices, 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
- Cleveland, OH, US
Recent devices under product code HRX
view allMore clearances from Micro-Medical Devices, Inc.
view all- K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
- K963675 — THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
- K951482 — ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)
- K951894 — ACCESS EXPANSION SYSTEM
- K945656 — THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
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.