DOBBHOFF(R) POLYPECTOMY SNARE— 510(k) K901322
Substantially EquivalentBiosearch Medical Products, Inc.
FDA 510(k) clearance K901322 for DOBBHOFF(R) POLYPECTOMY SNARE, Substantially Equivalent on 1990-06-15. Applicant: Biosearch Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosearch Medical Products, Inc.
- Product code
- Code FDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
Recent devices under product code FDI
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- K970145 — PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
- K964871 — BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
- K951260 — URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
- K944614 — MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
Adverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
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.