Cleared Traditional

K800058 - ANAGO ELECTRO SURGICAL TIP CLEANER

K800058 is an FDA 510(k) clearance for ANAGO ELECTRO SURGICAL TIP CLEANER, manufactured by Anago, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEC cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K800058 · Anago, Inc. · General & Plastic Surgery device
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Jan 1980
Decision
18d
Days
Class 1
Risk

K800058 is an FDA 510(k) clearance for the ANAGO ELECTRO SURGICAL TIP CLEANER. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by Anago, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1980 after a review of 18 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 Anago, Inc. devices

FDA 510(k) Submission Details - K800058

510(k) Number K800058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1980
Decision Date January 28, 1980
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 20
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K800058.
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · The Kendal Co. · Jan 1982
DISPOSABLE SCRUB BRUSH
K810655 · Dexide, Inc. · May 1981
HEAVY DRAINAGE PACK
K803116 · American Medical Disposable, Inc. · Jan 1981
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO
K792272 · Dexide, Inc. · Dec 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K792271 · Dexide, Inc. · Dec 1979
DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P
K792273 · Dexide, Inc. · Dec 1979