Cleared Traditional

K072028 - QUILL SELF-RETAINING SYSTEM (SRS) COMPR...

K072028 is an FDA 510(k) clearance for QUILL SELF-RETAINING SYSTEM (SRS) COMPR..., manufactured by Surgical Specialties Corp. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K072028 · Surgical Specialties Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
10d
Days
Class 2
Risk

K072028 is an FDA 510(k) clearance for the QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on August 3, 2007 after a review of 10 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 Surgical Specialties Corp devices

FDA 510(k) Submission Details - K072028

510(k) Number K072028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2007
Decision Date August 03, 2007
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
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 86
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K072028.
VILET VILET QUICK
K120556 · Riverpoint Medical · May 2012
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
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
K052437 · Surgical Specialties Corp · Nov 2005