510(k) Report

FDA applicant

Symmetry Surgical, Inc.

Antioch, TN5 decisions2013–20180 recalls

FDA records 5 decisions for Symmetry Surgical, Inc. (Antioch, TN) from 2013 to 2018: 5 510(k) clearances. Most are in product codes HAE (Rongeur, Manual) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Symmetry Surgical”.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2018

2013: 12015: 12016: 22018: 1
2013high 2 (2016) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Symmetry Surgical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • HAERongeur, Manual2decisions
  • GCJLaparoscope, General & Plastic Surgery1decision
  • DXCClamp, Vascular1decision
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 120 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 182 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130541Symmetry Kerrison Disposable Tip RongeursSymmetry Surgical · 20131cites it

What has FDA decided for it lately?

  • K173272Ergonomic HandleSymmetry Surgical, Inc. · 2018
  • K161744Symmetry Sharp Kerrison RongeurSymmetry Surgical, Inc. · 2016
  • K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. · 2016
  • K143078Bookwalter Gordon Adjustable Compression ElementSymmetry Surgical · 2015
  • K130541Symmetry Kerrison Disposable Tip RongeursSymmetry Surgical · 2013

All 3 as Symmetry Surgical, Inc. →All 2 as Symmetry Surgical →

Other applicant names beginning “Symmetry”

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

Symmetry Medical 3Symmetry Medical USA, Inc. 1Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. 1Symmetry Medical Inc- Manchester 1