Cleared Traditional

K971208 - MEDLINE INDUSTRIES

K971208 is the FDA 510(k) clearance for MEDLINE INDUSTRIES by Medline Industries, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAM) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K971208 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
41d
Days
Class 2
Risk

K971208 is an FDA 510(k) clearance for the MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Waukegan, US). The FDA issued a Cleared decision on May 13, 1997 after a review of 41 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K971208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date May 13, 1997
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K971208.
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
K980704 · Aesculap, Inc. · May 1998
PANACRYL
K974299 · Ethicon, Inc. · Feb 1998
DEXON VIOLET
K972566 · Davis & Geck, Inc. · Aug 1997
MODIFIED USSC* POLYSORB SUTURE
K970863 · United States Surgical, A Division of Tyco Healthc · May 1997
MODIFIED E-PACK PROCEDURE KIT
K970317 · Ethicon, Inc. · Apr 1997
ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
K964345 · Ethicon, Inc. · Dec 1996