Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter— 510(k) K242225
Substantially EquivalentSurgical Instrument Service and Savings, Inc.
FDA 510(k) clearance K242225 for Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter, Substantially Equivalent on 2024-11-29. Applicant: Surgical Instrument Service and Savings, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Product code
- Code NLH
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
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Recalls naming K242225
K-number listed on FDA's recall record- Z-1320-2026 — Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH
- Z-2612-2025 — Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K242225.
Data sourced from openFDA. This site is unofficial and independent of the FDA.