Cleared Traditional

K203548 - EndoArmor + Surgical Gown

K203548 is the FDA 510(k) clearance for EndoArmor + Surgical Gown by Boston Scientific Corporation. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 444-day FDA review.

K203548 · Boston Scientific Corporation · General Hospital
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Feb 2022
Decision
444d
Days
Class 2
Risk

K203548 is an FDA 510(k) clearance for the EndoArmor™ + Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on February 21, 2022 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K203548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2020
Decision Date February 21, 2022
Days to Decision 444 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
315d slower than avg
Panel avg: 129d · This submission: 444d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K203548.
Maxima Surgical Gown
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Surgical Gown, Model: surgical gown-hp-3
K210355 · Weihai Dishang Medical Technology Co., Ltd. · Dec 2021