FDA applicant

Microline Surgical, Inc.

Beverly, MA8 decisions2012–20241 recall

FDA records 8 decisions for Microline Surgical, Inc. (Beverly, MA) from 2012 to 2024: 8 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 147 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 1 of them its own earlier devices. 1 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 Microline Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2012high 3 (2016) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2024

2012high 1 (2024) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Microline Surgical, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microline Surgical, 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

Other applicant names beginning “Microline”

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

Microline Scientific 14 Microline Pentax, Inc. 12

Microline Surgical, Inc.

Which product codes does it file in?

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What has FDA decided for it lately?

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Other applicant names beginning “Microline”