Cleared Traditional

K843575 - DERBYSHIRE DRAIN

K843575 is an FDA 510(k) clearance for DERBYSHIRE DRAIN, manufactured by Sil-Med Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K843575 · Sil-Med Corp. · General & Plastic Surgery device
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Oct 1984
Decision
43d
Days
Class 1
Risk

K843575 is an FDA 510(k) clearance for the DERBYSHIRE DRAIN. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Sil-Med Corp. devices

FDA 510(k) Submission Details - K843575

510(k) Number K843575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1984
Decision Date October 24, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

GBW Device Classification - Class 1, General Controls

Product Code GBW Catheter, Peritoneal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBW Catheter, Peritoneal

All 13
Devices cleared under the same product code (GBW) and FDA review panel - the closest regulatory comparables to K843575.
ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER
K933510 · Sherwood Medical Co. · Feb 1994
BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO
K926477 · Core Dynamics, Inc. · Nov 1993
NELSON-JUNG PLEURAL CATH
K854812 · Research Medical, Inc. · Feb 1986
FLAT DRAIN
K813063 · Sil-Med Corp. · Dec 1981
ARROW PERITONEAL LAVAGE CATHERIZATION K
K811627 · Arrow Intl., Inc. · Aug 1981
PERCUTANEOUS DRAINING CATHETER
K811378 · Medi-Tech, Inc. · Jun 1981