Cleared Traditional

K200767 - SilverStream Gel

K200767 · Enzysurge , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
197d
Days
-
Risk

K200767 is an FDA 510(k) clearance for the SilverStream Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Enzysurge , Ltd. (Rosh Ha'Ayin, IL). The FDA issued a Cleared decision on October 8, 2020 after a review of 197 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Enzysurge , Ltd. devices

Submission Details

510(k) Number K200767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2020
Decision Date October 08, 2020
Days to Decision 197 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Bioreg Services
Daniel Albahari

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 - FRO Dressing, Wound, Drug

All 211
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K200767.
Antibacterial Bandage
K201324 · Jiangsu Excellence Medical Supplies Co., Ltd. · Feb 2021
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
K201016 · Huizhou Foryou Medical Devices Co., Ltd. · Jan 2021
anti-bacterial bandage
K200821 · Planet (Suzhou) Medical Products Co., Ltd. · Oct 2020
MEBO Wound Dressing
K193439 · Mebo Life Science, Inc. · Sep 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
K200835 · 3M Company · Sep 2020
HaloGUARD Protective Disc with CHG
K200641 · Attwill Medical Solutions · Sep 2020