Cleared Traditional

K872823 - DELTA SCRUB

K872823 is an FDA 510(k) clearance for DELTA SCRUB, manufactured by Pacific Biosystems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K872823 · Pacific Biosystems, Inc. · General & Plastic Surgery device
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Jan 1988
Decision
175d
Days
Class 1
Risk

K872823 is an FDA 510(k) clearance for the DELTA SCRUB. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Pacific Biosystems, Inc. (Phoenix, US). The FDA issued a Cleared decision on January 7, 1988 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pacific Biosystems, Inc. devices

FDA 510(k) Submission Details - K872823

510(k) Number K872823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1987
Decision Date January 07, 1988
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

GEC Device Classification - Class 1, General Controls

Product Code GEC Brush, Scrub, Operating-room
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 - GEC Brush, Scrub, Operating-room

All 24
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K872823.
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
K971473 · M-Pact Worldwide Management Corp. · Jul 1997
EXPANDACELL INSTRUMENT WIPE
K960621 · Shippert Medical Technologies Corp. · Apr 1996
STERILE SCRUBBY SCRUB BRUSH
K875033 · Medsurg Industries, Inc. · Feb 1988
STERILE SURGICAL SCRUB BRUSH
K874653 · Surgikos, Inc. · Dec 1987
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES
K854232 · American Pharmaseal Div. Ahsc · Dec 1985
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · American Sterilizer Co. · Dec 1984