Cleared Traditional

K053638 - MANI NEEDLE & SUTURE PACK (SILK)

K053638 is an FDA 510(k) clearance for MANI NEEDLE & SUTURE PACK (SILK), manufactured by Mani, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K053638 · 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

K053638 is an FDA 510(k) clearance for the MANI NEEDLE & SUTURE PACK (SILK). Classified as Suture, Nonabsorbable, Silk (product code GAP), 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 878.5030 - 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 - K053638

510(k) Number K053638 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.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 40
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K053638.
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
K160623 · M/s. Meril Endo Surgery Private Limited. · May 2016
WG-SURGICAL SUTURES WITH NEEDLE
K080684 · Foosin Medical Supplies, Inc. · Jun 2008
NON-ABSORBABLE SILK SUTURE
K071111 · Arrow Intl., Inc. · Jul 2007
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
K041514 · Sutures India Private Limited · Jun 2005
UNISILK
K042282 · United Medical Industries Co. , Ltd. · Dec 2004
SILK SUTURES
K024091 · Aurolab · Feb 2003
K053638 · MANI NEEDLE & SUTURE PACK (SILK)
Download PDF FDA Summary Mani, Inc.