PBC Needle by Nipro Med Industries

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K820911 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• PBC Needle

  Class II

  FDA 510(k) K813649 Active Cleared 28 Jan 1982

• Intravenous Injection Set

  Class II

  FDA 510(k) K841717 Active Cleared 23 Jul 1984

• Jms Needle & Mac Ject

  Class II

  FDA 510(k) K813648 Active Cleared 28 Jan 1982

• Pbc Syringe Irrigating

  Class II

  FDA 510(k) K834256 Active Cleared 23 Mar 1984

• Pbc IV Set Non-Vented

  Class II

  FDA 510(k) K834253 Active Cleared 27 Feb 1984

• Pbc Extension Set

  Class II

  FDA 510(k) K834252 Active Cleared 27 Feb 1984

See all devices from Philadelphia Biologics Center →

• What is the PBC Needle by Nipro Med Industries used for?

  The PBC Needle by Nipro Med Industries is a hypodermic, single lumen needle intended for general hospital use, as stated in its description and product code classification under FMI.

• Is the PBC Needle by Nipro Med Industries reusable or single-use?

  The device is supplied as a single-use device and is not designed for reuse, as explicitly specified in the device data under its specifications and intended use.

• What regulatory pathway was used for the PBC Needle by Nipro Med Industries?

  The PBC Needle by Nipro Med Industries received FDA 510(k) clearance (K820911) through a traditional review process, as documented in the authorizations and decision details.

• Is the PBC Needle by Nipro Med Industries MRI conditional?

  The device is not MRI conditional unless explicitly stated in labeling, as noted in the description section, which clarifies that MRI conditionality is not assumed without specific labeling.