COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
FDA 510(k) clearance K962288 · decided 1997-01-30
Clearance details
- K-number
- K962288
- Device name
- COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
- Applicant
- Pinnacle Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-14
- Decision date
- 1997-01-30
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- MMP
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (K091178) | Mtp Medical Technical Promotion GmbH | 2009-07-31 |
| LIGHT DRAPE (K043234) | Wrapped IN Comfort | 2005-05-25 |
| GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (K041501) | Guangzhou Fortunique , Ltd. | 2004-11-30 |
| INCUBATOR CAPE (K040794) | Wrapped IN Comfort | 2004-06-10 |
| MEDLINE BAND BAGS AND EQUIPMENT COVERS (K032065) | Medline Industries, Inc. | 2003-09-22 |
| SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (K023540) | Valumed | 2003-02-04 |
| MEDSURG EQUIPMENT COVERS (K014239) | International Medsurg Connection | 2002-02-19 |
| ULTRASOUND SYSTEMS DRAPE (K970885) | Protek Medical Products, Inc. | 1997-09-22 |
| EQUIPMENT COVERS (K961699) | United States Surgical, A Division of Tyco Healthc | 1996-08-23 |
| PROTOUCH OVERGLOVE (K952241) | Cottrell, Ltd. | 1995-08-07 |
| STERILE EQUIPMENT COVERS (K931417) | Custom Medical Products, Ltd. | 1995-07-06 |
| SURGICAL MICROSCOPE DRAPE (K944198) | Hydro-Med Products, Inc. | 1994-11-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Str recall (Z-1306-2015) | Penner Mfg Inc | 2015-03-20 |
| Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total C recall (Z-1291-2015) | Sybron Dental Specialties | 2015-03-18 |
| Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended recall (Z-0444-2013) | Metrex Research, LLC. | 2012-11-27 |