Cleared Special

K261484 - Tissue Approximation System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K261484 · Tas Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
29d
Days
Class 2
Risk

K261484 is an FDA 510(k) clearance for the Tissue Approximation System. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Tas Medical, Inc. (Windermere, US). The FDA issued a Cleared decision on June 3, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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 Tas Medical, Inc. devices

Submission Details

510(k) Number K261484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2026
Decision Date June 03, 2026
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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

Oconnell Regulatory Consultants, Inc.
Maureen OConnell

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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K261484.
Tissue Approximation System (TAS)
K220980 · Tas Medical, Inc. · Jul 2023
Golnit Nylon Monofilament Suture
K212888 · Antarma, LLC Dba Golnit Sutures · Mar 2022
Non Absorbable Surgical Nylon Suture
K212603 · Shandong Haidike Medical Product Co., Ltd. · Dec 2021
Crownjun Nylon Suture
K192420 · Kono Seisakusho Co., Ltd. · May 2020