ProTector PNS500
ProTector PNS500 (PNS500-1) is a Class II device made by Certol International, LLC, cleared under FDA 510(k) K052725 on 28 Dec 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI H816PNS5001), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberH816PNS5001 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052725 | Date28 Dec 2005 | StatusActive |
Official records
- FDA 510(k) database K052725
Across registries
- FDA 510(k) K052725 decided 28 Dec 2005 Active
- FDA GUDID UDI-DI H816PNS5001 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K052725
- Listed FDA GUDID H816PNS5001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ProTector
- Generic name
- Surgical instrument containment holder, single-use, non-sterile
- Model / Ref / Catalog
- PNS500, PNS500-1
- Primary DI / UDI-DI
- H816PNS5001
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Surgical instrument containment holder, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).
- STERI-STAT REUSABLE SYRINGE by David Craig Marketing, Inc.
- SHARPSPRO-TECTOR by Superior Diapering Products, Ltd.
- JMS NEEDLE & MAC JECT by Philadelphia Biologics Center
- NON-STERILE REUSABLE NEEDLES by Vertex Medical Corp.
- A+MED DISPOSABLE NEEDLE by Can-Am Surgical Corp.
- VACU-MED BLOOD COLLECTION NEEDLES by Shina Corp.
- RINN E-Z CAPPER by Rinn Corp.
- DISPOSABLE HYPODERMIC NEEDLE by Feeltech Co., Ltd.
- MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION by Kawasumi Laboratories Co., Ltd.
- SHIELDING NEEDLE HOLDER by U.S. Safety Syringes Co., Inc.