Cleared Traditional

K202071 - SURGIPHOR Wound Irrigation System

K202071 is the FDA 510(k) clearance for SURGIPHOR Wound Irrigation System by Orthophor, LLC. It is a Class 2 General & Plastic Surgery device (product code FQH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K202071 · Orthophor, LLC · General & Plastic Surgery device
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Oct 2020
Decision
88d
Days
Class 2
Risk

K202071 is an FDA 510(k) clearance for the SURGIPHOR Wound Irrigation System. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Orthophor, LLC (Philadelphia, US). The FDA issued a Cleared decision on October 23, 2020 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5475 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthophor, LLC devices

Submission Details

510(k) Number K202071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date October 23, 2020
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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

Secure BioMed Evaluations
Elizabeth O’Keeffe

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 - FQH Lavage, Jet

All 31
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K202071.
BD Surgiphor Antimicrobial Irrigation System
K213616 · Becton, Dickinson and Company · Mar 2022
Irrisept Antimicrobial Wound Lavage
K210536 · Irrimax Corporation · May 2021
Irrisept Wound Debridement and Cleansing System
K202222 · Irrimax Corporation · Dec 2020
Bactisure Wound Lavage
K192349 · Next Science, LLC · Jan 2020
The VersaJet II Hydrosurgery System
K143115 · Smith & Nephew, Inc. · Jul 2015
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
K110958 · Smith & Nephew, Inc. · Aug 2011