INSTANT WARM GEL PACK— 510(k) K912715
Substantially EquivalentPrism Technologies, Inc.
FDA 510(k) clearance K912715 for INSTANT WARM GEL PACK, Substantially Equivalent on 1991-10-02. Applicant: Prism Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Prism Technologies, Inc.
- Product code
- Code IMD
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code IMD
view allMore clearances from Prism Technologies, Inc.
view allAdverse events under product code IMD
product code IMD- Death
- 3
- Injury
- 600
- Total
- 603
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 K912715
K-number listed on FDA's recall record- Z-1298-2015 — CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
- Z-1299-2015 — Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection
- Z-1300-2015 — MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection
- Z-1301-2015 — NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K912715.
Data sourced from openFDA. This site is unofficial and independent of the FDA.