Cleared Traditional

K053637 - MANI NEEDLE & SUTURE PACK (NYLON)

K053637 is an FDA 510(k) clearance for MANI NEEDLE & SUTURE PACK (NYLON), manufactured by Mani, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K053637 · Mani, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
141d
Days
Class 2
Risk

K053637 is an FDA 510(k) clearance for the MANI NEEDLE & SUTURE PACK (NYLON). Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Mani, Inc. (Washington, US). The FDA issued a Cleared decision on May 19, 2006 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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: 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.

FDA 510(k) Submission Details - K053637

510(k) Number K053637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2005
Decision Date May 19, 2006
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K053637.
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · Unilene Sac · May 2013
KUMAR T-ANCHORS HERNIA SET
K081366 · Nashville Surgical Instruments · Jul 2008
FSSB NYLON SURGICAL SUTURES
K060471 · Fssb Chirurgische Nadeln GmbH · Jul 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
QUILL NONABSORBABLE NYLON BARBED SUTURE
K052900 · Quill Medical, Inc. · Nov 2005
ARTELON SURGICAL SUTURE
K052482 · Artimplant AB · Oct 2005
K053637 · MANI NEEDLE & SUTURE PACK (NYLON)
Download PDF FDA Summary Mani, Inc.