Cleared Traditional

K102659 - MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER

K102659 · Manuka Medical Limited · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
84d
Days
-
Risk

K102659 is an FDA 510(k) clearance for the MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Manuka Medical Limited (Laguna Niguel, US). The FDA issued a Cleared decision on December 8, 2010 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K102659

510(k) Number K102659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2010
Decision Date December 08, 2010
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 685
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K102659.
BIOMED WOUND CLEANSER
K100613 · Biomed Laboratories, Inc. · Jan 2011
ACTIVON TULLE
K101118 · Calidad Solutions, Inc. · Dec 2010
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
K100261 · Tei Biosciences, Inc. · Dec 2010
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882 · B.Braun Medical, Inc. · Nov 2010
OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
K102478 · Southwest Technologies, Inc. · Nov 2010
EXSALT WOUND DRESSING
K100580 · Exciton Technologies, Inc. · Oct 2010
K102659 · MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
Download PDF FDA Summary Manuka Medical Limited