510(k) Report

FDA applicant

Procedure Pak, Inc.

Asheville, NC2 decisions1986–19870 recalls

FDA records 2 decisions for Procedure Pak, Inc. (Asheville, NC) from 1986 to 1987: 2 510(k) clearances. Most are in product codes FSM (Tray, Surgical, Instrument) and KKX (Drape, Surgical, Antimicrobial). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Procedure Pak, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Procedure Pak, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Procedure Pak, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FSMTray, Surgical, Instrument1decision
  • KKXDrape, Surgical, Antimicrobial1decision

What has FDA decided for it lately?

  • K871478Surgical Packs, Surgical Kits and Surgical TraysProcedure Pak, Inc. · 1987
  • K861288Non-Sterile & Sterile Disposable Surgical DrapesProcedure Pak, Inc. · 1986

All 2 as Procedure Pak, Inc. →

Other applicant names beginning “Procedure”

FDA records each applicant name separately; these may or may not be the same firm.

Procedure Products, Inc. 16Procedure Packs, Inc. 4