Atraumatic Standard Sprotte Needle

510(k) K911260

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

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	NumberK911260	Date21 Oct 1991Cleared	StatusActive

5 recalls · 4 ongoing · FDA

- Ongoing Z-2389-2026 FDA Class I initiated 21 Apr 2026
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
2 recalls, same reason
- Ongoing Z-2129-2020 FDA Class II initiated 11 Oct 2019
- Ongoing Z-2130-2020 FDA Class II initiated 11 Oct 2019
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
- Ongoing Z-0234-2020 FDA Class II initiated 30 Aug 2019
Problem with packaging sealing process which affects sterility.
- Terminated Z-1250-2020 FDA Class II initiated 20 Dec 2019
Product lidstock contains the incorrect expiration date for the product

1 jurisdiction

United States — FDA 510(k) Active

510(k)