COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER— 510(k) K962288
Substantially EquivalentPinnacle Products, Inc.
FDA 510(k) clearance K962288 for COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER, Substantially Equivalent on 1997-01-30. Applicant: Pinnacle Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Pinnacle Products, Inc.
- Product code
- Code MMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code MMP
view allRecalls naming K962288
K-number listed on FDA's recall record- Z-1291-2015 — Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500
- Z-1306-2015 — Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.
- Z-0444-2013 — Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962288.
Data sourced from openFDA. This site is unofficial and independent of the FDA.