510(k) Report

FDA applicant

Specialty Surgical Products, Inc.

Hamilton, MT13 decisions1997–20140 recalls

FDA records 13 decisions for Specialty Surgical Products, Inc. (Hamilton, MT) from 1997 to 2014: 13 510(k) clearances. Most are in product codes LCJ (Tissue Expander And Accessories) and MIB (Elastomer, Silicone Block). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Specialty Surgical Products”.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Specialty Surgical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Specialty Surgical Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LCJTissue Expander And Accessories4decisions
  • MIBElastomer, Silicone Block3decisions
  • MRDMammary Sizer2decisions
  • EMXBalloon, Epistaxis1decision
  • FTQProsthesis, Penis, Rigid Rod1decision
  • FTLMesh, Surgical, Polymeric1decision

Also: FGE (1).

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070303Silicone Tissue ExpanderSpecialty Surgical Products · 20072cite it
  • K974653Silicone Elastomer SheetingSpecialty Surgical Products, Inc. · 19981cites it
  • K140383ALLOX2 Tissue ExpandersSpecialty Surgical Products, Inc. · 20141cites it

What has FDA decided for it lately?

  • K140383ALLOX2 Tissue ExpandersSpecialty Surgical Products, Inc. · 2014
  • K070303Silicone Tissue ExpanderSpecialty Surgical Products · 2007
  • K984106Mammary Sizer, Mammary Prothesis SizerSpecialty Surgical Products, Inc. · 1999
  • K983015Virilis Penile ProsthesisSpecialty Surgical Products, Inc. · 1999
  • K982258Mammary SizerSpecialty Surgical Products, Inc. · 1998
  • K982065Sterile Silicone External Wound CoverSpecialty Surgical Products, Inc. · 1998
  • K982067Magnetic Port Silicone Tissue ExpanderSpecialty Surgical Products, Inc. · 1998
  • K974653Silicone Elastomer SheetingSpecialty Surgical Products, Inc. · 1998

All 12 as Specialty Surgical Products, Inc. →The one decision as Specialty Surgical Products →

Other applicant names beginning “Specialty”

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

Specialty Ultravision, Inc. 12Specialty Packaging Producs, Inc. 11Specialty Medical Products Co. 4Specialty Appliance Works, Inc. 3Specialty Medical Industries, Inc. 3Specialty Water Technologies 2Specialty Spine Products, LLC 2Specialty Fibres and Materials, Ltd. 2Specialty Health Products, Inc. 2Specialty Dialysis Services 1Specialty Drives Technologies, Inc. 1Specialty Tint 1