Cleared Traditional

K062366 - OPTIME

K062366 is an FDA 510(k) clearance for OPTIME, manufactured by Peters Surgical. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K062366 · Peters Surgical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
49d
Days
Class 2
Risk

K062366 is an FDA 510(k) clearance for the OPTIME, SINUSORB PGA. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Peters Surgical (Bobigny Cedex, FR). The FDA issued a Cleared decision on October 2, 2006 after a review of 49 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 Peters Surgical devices

FDA 510(k) Submission Details - K062366

510(k) Number K062366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2006
Decision Date October 02, 2006
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 80
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K062366.
HEPATOSTAT SET
K073493 · Vygon Corp. · May 2008
MONOSWIFT
K072229 · Cp Medical · Oct 2007
HEPATOSTAT SET, MODEL 760X
K061796 · Vygon Corp. · Nov 2006
DEKNA-LOK MODEL BP1000V2L
K060801 · Teleflex Medical · May 2006
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · Ethicon, Inc. · Jun 2005
LUPINE LOOP
K050771 · Depuy Mitek, A Johnson & Johnson Company · Apr 2005