IP-SET— 510(k) K101685
Substantially EquivalentIntegral Process Sas
FDA 510(k) clearance K101685 for IP-SET, Substantially Equivalent on 2010-07-01. Applicant: Integral Process Sas. Device class: 2.
Clearance details
- Applicant
- Integral Process Sas
- Product code
- Code DRX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Conflans Sainte Honorine, FR
Recent devices under product code DRX
view allMore clearances from Integral Process Sas
view allAdverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
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 →
Recalls naming K101685
K-number listed on FDA's recall record- Z-0935-2022 — CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
- Z-0936-2022 — CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
- Z-0937-2022 — CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
- Z-0938-2022 — CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
- Z-0939-2022 — CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
- Z-0940-2022 — CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101685.
Data sourced from openFDA. This site is unofficial and independent of the FDA.