510(k) Report

FDA applicant

Mastel Precision Surgical Instruments, Inc.

Rapid City, SD1 decision2005–20050 recalls

FDA records 1 decision for Mastel Precision Surgical Instruments, Inc. (Rapid City, SD) in 2005: 1 510(k) clearance. All are in product code FYD (Apparatus, Exhaust, Surgical). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Mastel Precision Surgical Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mastel Precision Surgical Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mastel Precision Surgical Instruments, 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?

  • FYDApparatus, Exhaust, Surgical1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K043494Mastel Laser Clean Room, Model Ebs-100Mastel Precision Surgical Instruments, Inc. · 2005

The one decision as Mastel Precision Surgical Instruments, Inc. →

Other applicant names beginning “Mastel”

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

Mastel Precision, Inc. 1Mastel Surgical 1