EPIDURAL ANESTHESIA NEEDLES— 510(k) K854816
Substantially EquivalentReganes, Inc.
FDA 510(k) clearance K854816 for EPIDURAL ANESTHESIA NEEDLES, Substantially Equivalent on 1985-12-19. Applicant: Reganes, Inc.. Device class: 2.
Clearance details
- Applicant
- Reganes, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Recent devices under product code BSP
view allMore clearances from Reganes, Inc.
view allAdverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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 K854816
K-number listed on FDA's recall record- Z-2056-2015 — Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.
- Z-1544-2015 — Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K854816.
Data sourced from openFDA. This site is unofficial and independent of the FDA.