Cleared Traditional

K875033 - STERILE SCRUBBY SCRUB BRUSH

K875033 is an FDA 510(k) clearance for STERILE SCRUBBY SCRUB BRUSH, manufactured by Medsurg Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K875033 · Medsurg Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
74d
Days
Class 1
Risk

K875033 is an FDA 510(k) clearance for the STERILE SCRUBBY SCRUB BRUSH. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 74 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 Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K875033

510(k) Number K875033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received December 07, 1987
Decision Date February 19, 1988
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
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 22
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K875033.
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
K971473 · M-Pact Worldwide Management Corp. · Jul 1997
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
FOAM CARE ONE STEP PREP
K843636 · Ballard Medical Products · Nov 1984
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
K831226 · Ballard Medical Products · May 1983