Cleared Special

K171494 - TroClose1200, TroClose1200 Cannula

K171494 is an FDA 510(k) clearance for TroClose1200, manufactured by Gordian Surgical, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Special 510(k) pathway after a 24-day FDA review.

K171494 · Gordian Surgical, Ltd. · General & Plastic Surgery device
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Jun 2017
Decision
24d
Days
Class 2
Risk

K171494 is an FDA 510(k) clearance for the TroClose1200, TroClose1200 Cannula. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Gordian Surgical, Ltd. (Misgav Business Park, IL). The FDA issued a Cleared decision on June 15, 2017 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gordian Surgical, Ltd. devices

FDA 510(k) Submission Details - K171494

510(k) Number K171494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2017
Decision Date June 15, 2017
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Dr. Susan Alpert
Susan Alpert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 144
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K171494.
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
K170166 · Cpt Sutures Co., Ltd. · Sep 2017
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
K172659 · M/s. Meril Endo Surgery Private Limited. · Sep 2017
Silhouette InstaLift
K163676 · Silhouette Lift, Inc. · Jun 2017
Novosyn Quick Absorbable Suture
K170661 · Aesculap, Inc. · Jun 2017
CRYLREX
K161629 · Sm Eng Co., Ltd. · Feb 2017
TroClose1200
K160564 · Gordian Surgical, Ltd. · Nov 2016