510(k) Report

FDA applicant

Charles Polo & Co., Inc.

Garden Grove, CA2 decisions1988–19940 recalls

FDA records 2 decisions for Charles Polo & Co., Inc. (Garden Grove, CA) from 1988 to 1994: 2 510(k) clearances. Most are in product codes HIF (Insufflator, Laparoscopic) and FTA (Light, Surgical, Accessories). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Charles Polo & Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Charles Polo & Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Charles Polo & Co., 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?

  • HIFInsufflator, Laparoscopic1decision
  • FTALight, Surgical, Accessories1decision

What has FDA decided for it lately?

  • K935639Insufflation Tubing Sterile and Non-SterileCharles Polo & Co., Inc. · 1994
  • K882132Light, Surgical AccessoriesCharles Polo & Co., Inc. · 1988

All 2 as Charles Polo & Co., Inc. →

Other applicant names beginning “Charles”

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

Charles L. Rose and Co., Inc. 4Charles A. Smith 2Charles Atkins & Co. 2Charles I. Rose & Co., Inc. 1Charles F. Samelson, M.D. 1Charles D. Bell, Inc. 1Charles Scharf 1