Shave Prep Trays (Non-Sterile)

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

510(k) Number

K925214 ↗

FDA Product Code

LRO

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESK Substantially Equivalent — Kit

• Sterile Skin Scrub Trays

  Class II

  FDA 510(k) K925216 Active Cleared 22 Jun 1993

• Sterile Surgical Instrument Trays

  Class I

  FDA 510(k) K925215 Active Cleared 1 Jun 1993

• Premiere Sterile Suture Removal Kit(Hc-50-54957)

  Class I

  FDA 510(k) K924834 Active Cleared 23 Mar 1993

• Valu-Pak Sterile Suture Removal Kit (Ahc-50-549560

  Class I

  FDA 510(k) K924835 Active Cleared 23 Mar 1993

• What is the intended use of the Shave Prep Trays (Non-Sterile)?

  The Shave Prep Trays (Non-Sterile) are procedural trays designed to organize and hold necessary items for preoperative skin preparation prior to medical procedures, supporting efficiency in clinical workflows in general and plastic surgery settings as indicated by the advisory committee classification.

• How are the Shave Prep Trays (Non-Sterile) supplied and are they sterile?

  The trays are supplied in a non-sterile condition and are intended for single-use only, with no claims of sterility made by the manufacturer.

• What regulatory pathway was used to authorize the Shave Prep Trays (Non-Sterile)?

  The device is authorized under FDA 510(k) clearance K925214, which is a traditional 510(k) submission, as indicated by the clearance_type field in the device data.

• What product code is assigned to the Shave Prep Trays (Non-Sterile) under the FDA classification system?

  The device is assigned product code LRO, which is used to categorize the device type within the FDA’s product code system for regulatory tracking and review.