Cleared Traditional

K932219 - SUTURE SET OR LACERATION TRAYS (PACKS)

K932219 is an FDA 510(k) clearance for SUTURE SET OR LACERATION TRAYS (PACKS), manufactured by Associated Medical Products Co.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K932219 · Associated Medical Products Co. · General & Plastic Surgery device
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Jul 1993
Decision
63d
Days
Class 1
Risk

K932219 is an FDA 510(k) clearance for the SUTURE SET OR LACERATION TRAYS (PACKS). Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Associated Medical Products Co. (St. Louis Park, US). The FDA issued a Cleared decision on July 9, 1993 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Associated Medical Products Co. devices

FDA 510(k) Submission Details - K932219

510(k) Number K932219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 07, 1993
Decision Date July 09, 1993
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KDD Kit, Surgical Instrument, Disposable

All 19
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K932219.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
K072814 · Covidien · Apr 2008
DEXIDE LAPAROSCOPIC KITS
K924117 · Dexide, Inc. · Mar 1993
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
K920516 · Trinity Laboratories, Inc. · Apr 1992
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · Baxter Healthcare Corp · Jul 1991
MEGA GENERAL PURPOSE INSTRUMENT KIT
K910366 · Megadyne Medical Products, Inc. · Mar 1991
INCISION AND DRAINAGE KIT
K910369 · Megadyne Medical Products, Inc. · Mar 1991