Cleared Traditional

X-Tack Endoscopic HeliX Tacking System (K201808) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201808 · Apollo Endosurgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
167d
Days
Class 2
Risk

K201808 is an FDA 510(k) clearance for the X-Tack Endoscopic HeliX Tacking System. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on December 15, 2020 after a review of 167 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Apollo Endosurgery, Inc. devices

Submission Details

510(k) Number K201808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2020
Decision Date December 15, 2020
Days to Decision 167 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 130d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKL Hemostatic Metal Clip For The Gi Tract
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
Definition Clip Placement Within The Gastrointestinal (gi) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supplemental Closure Method Of Luminal Perforations.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PKL Hemostatic Metal Clip For The Gi Tract

All 51
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K201808.
Disposable Dual Action Tissue Clip
K212748 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2022
Instinct Plus Endoscopic Clipping Device
K212323 · Wilson-Cook Medical, Inc. · Aug 2021
Lockado Repositionable Hemostasis Clip
K202333 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2021
Single Use Rotatable and Repositionable Hemoclip
K201771 · Anrei Medical (Hangzhou) Co., Ltd. · Oct 2020
ClearEndoclip
K200217 · Finemedix Co., Ltd. · Oct 2020
Resolution 360™ ULTRA Clip
K193424 · Boston Scientific Corporation · Sep 2020