Pbc Syringe

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

510(k) Number

K813647 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

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 Needle by Nipro Med Industries

  Class II

  FDA 510(k) K820911 Active Cleared 15 Apr 1982

See all devices from Philadelphia Biologics Center →

• What is the intended use of the PBC Syringe?

  The PBC Syringe is designed for use within general hospital settings. It is classified under product code FMF, which relates to devices used in general hospital environments.

• What is the regulatory status of this device?

  The PBC Syringe has received FDA 510(k) clearance under K-number K813647. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

• Who is the manufacturer of the PBC Syringe?

  The PBC Syringe is manufactured by the Philadelphia Biologics Center, located in Walker, Michigan. The company submitted the device for regulatory review, which resulted in a decision of substantial equivalence in 1982.