Cleared Traditional

LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (K221102) - FDA 510(k) Clearance

K221102 · Sra Developments, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
245d
Days
-
Risk

K221102 is an FDA 510(k) clearance for the LOTUS Series 4 Enhanced Shears, LOTUS Series 5. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Sra Developments, Ltd. (Ashburton, GB). The FDA issued a Cleared decision on December 15, 2022 after a review of 245 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 Sra Developments, Ltd. devices

Submission Details

510(k) Number K221102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2022
Decision Date December 15, 2022
Days to Decision 245 days
Submission Type Traditional
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
130d slower than avg
Panel avg: 115d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 53
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K221102.
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K221235 · Misonix, Inc. · Jul 2022