Cleared Traditional

K053636 - MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)

K053636 is an FDA 510(k) clearance for MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE), manufactured by Mani, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K053636 · Mani, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
75d
Days
Class 2
Risk

K053636 is an FDA 510(k) clearance for the MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE). Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Mani, Inc. (Washington, US). The FDA issued a Cleared decision on March 14, 2006 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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 Mani, Inc. devices

FDA 510(k) Submission Details - K053636

510(k) Number K053636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2005
Decision Date March 14, 2006
Days to Decision 75 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
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 102
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K053636.
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K060828 · Coapt Systems, Inc. · Apr 2006
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
K052437 · Surgical Specialties Corp · Nov 2005
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · Ethicon, Inc. · Jun 2005
ENDOTINE RIBBON
K051415 · Coapt Systems, Inc. · Jun 2005