Cleared Traditional

K050150 - MANI NEEDLE & SUTURE PACK

K050150 is an FDA 510(k) clearance for MANI NEEDLE & SUTURE PACK, manufactured by Mani, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K050150 · Mani, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
315d
Days
Class 2
Risk

K050150 is an FDA 510(k) clearance for the MANI NEEDLE & SUTURE PACK. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Mani, Inc. (Washington, US). The FDA issued a Cleared decision on December 5, 2005 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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. Elevated predicate reliance profile. 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 Mani, Inc. devices

FDA 510(k) Submission Details - K050150

510(k) Number K050150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2005
Decision Date December 05, 2005
Days to Decision 315 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
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 126
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K050150.
AXYAFLEX POLYESTER SUTURE
K060165 · Axya Medical, Inc. · Sep 2006
TENOLIG
K060367 · Fournitures Hospitalieres Industrie · Aug 2006
ALLOFIX ANCHOR
K053339 · Musculoskeletal Transplant Foundation · Mar 2006
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc. · Oct 2005
MTF ALLOGRAFT ANCHOR
K042038 · Musculoskeletal Transplant Foundation · Dec 2004
ARTHREX SUTURE GRAFTING KIT
K041553 · Arthrex, Inc. · Dec 2004