Cleared Traditional

StitchKit COMBO (K202950) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202950 · Origami Surgical · General & Plastic Surgery device
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Feb 2021
Decision
146d
Days
Class 2
Risk

K202950 is an FDA 510(k) clearance for the StitchKit COMBO. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Origami Surgical (Dover, US). The FDA issued a Cleared decision on February 23, 2021 after a review of 146 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Origami Surgical devices

Submission Details

510(k) Number K202950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date February 23, 2021
Days to Decision 146 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 115d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 62
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K202950.
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
K221744 · Ethicon, Inc. · Nov 2022
MONOFIX PGCL, knotless wound closure device
K212810 · Samyang Holdings Corp., Ltd. · Aug 2022
StitchKit
K211792 · Origami Surgical Inc . · Jul 2021
Monocryl Plus Antibacterial Suture
K201996 · Ethicon, Inc. · Dec 2020
REXSIN
K200392 · Sm Eng Co., Ltd. · Jul 2020
Silhouette Instalift
K200140 · Silhouette Lift, Inc. · Mar 2020