Cleared Traditional

Turbett Instrument Pod (K202593) - FDA 510(k) Clearance

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

K202593 · Turbett Surgical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2021
Decision
253d
Days
Class 2
Risk

K202593 is an FDA 510(k) clearance for the Turbett Instrument Pod. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Turbett Surgical, Inc. (Rochester, US). The FDA issued a Cleared decision on May 19, 2021 after a review of 253 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Turbett Surgical, Inc. devices

Submission Details

510(k) Number K202593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2020
Decision Date May 19, 2021
Days to Decision 253 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 129d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Hospital devices follow this clearance model.

Regulatory Consultant

Fdc Services
David Furr

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 - FRG Wrap, Sterilization

All 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K202593.
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K212198 · Plasmapp Co,., Ltd. · Oct 2021
SIGMA Sterilization Pouch and Roll
K202462 · Sigma Medical Supplies Corporation · Apr 2021
Sterisheet Sterilization Wrap
K200335 · Andersen Sterilizers, Inc. · Nov 2020
Tyvek Sterilization Pouches with Chevron Seal
K200336 · Andersen Sterilizers, Inc. · Nov 2020