CHOLEDOCHOSCOPE SYSTEM— 510(k) K771367
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K771367 for CHOLEDOCHOSCOPE SYSTEM, Substantially Equivalent on 1977-08-02. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code FBN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
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- K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
- K090776 — MEGAPULSE LASER SYSTEM AND FIBERS
Adverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
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.