Cover-All, Drape-It-All, Chair Sleve, X-Ray Sleeve, Headrest Cover

510(k) K962288

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK962288	Date30 Jan 1997Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1291-2015 FDA Class II initiated 11 Feb 2015
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
- Terminated Z-1306-2015 FDA Class II initiated 30 Jan 2015
If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement.
- Terminated Z-0444-2013 FDA Class II initiated 20 Sep 2011
The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).

1 jurisdiction

United States — FDA 510(k) Active

510(k)