Cleared Traditional

K201113 - Resascope RS-01/B

K201113 is the FDA 510(k) clearance for Resascope RS-01/B by Advanced Medical Systems Group Srl. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K201113 · Advanced Medical Systems Group Srl · Orthopedic device
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Dec 2020
Decision
238d
Days
Class 2
Risk

K201113 is an FDA 510(k) clearance for the Resascope RS-01/B. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Advanced Medical Systems Group Srl (San Pietro Viminario, IT). The FDA issued a Cleared decision on December 21, 2020 after a review of 238 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Medical Systems Group Srl devices

Submission Details

510(k) Number K201113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2020
Decision Date December 21, 2020
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 364
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K201113.
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