OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR— 510(k) K031147
Substantially EquivalentEthicon Endo-Surgery, Inc.
FDA 510(k) clearance K031147 for OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR, Substantially Equivalent on 2004-01-12. Applicant: Ethicon Endo-Surgery, Inc.. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, Inc.
- Product code
- Code KNQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5365
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code KNQ
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- K101520 — ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
- K102632 — ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
Adverse events under product code KNQ
product code KNQ- Malfunction
- 1,844
- Total
- 1,844
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.