Skip to content

ProTector PNS500

by MicroCare, LLC

ProTector PNS500 (PNS500-1) is a Class II device made by MicroCare, LLC, cleared under FDA 510(k) K052725 on 28 Dec 2005 and listed in FDA GUDID since 26 Oct 2022 (UDI-DI H816MPNS5001), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K052725

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberH816MPNS5001 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052725 Date28 Dec 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052725 decided 28 Dec 2005 Active
  • FDA GUDID UDI-DI H816MPNS5001 listed 26 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052725
  2. Listed FDA GUDID H816MPNS5001

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProTector
Generic name
Surgical instrument interim-placement holder, single-use
Model / Ref / Catalog
PNS500, PNS500-1
Primary DI / UDI-DI
H816MPNS5001
510(k) Number
FDA product code
FMI
GMDN term
Surgical instrument interim-placement holder, single-use
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Surgical instrument interim-placement holder, single-use.

Other devices from MicroCare, LLC

See all devices from MicroCare, LLC →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)