Cleared Traditional

K893598 - HYDRAULIC FOOT OPERATED STOOL

K893598 is an FDA 510(k) clearance for HYDRAULIC FOOT OPERATED STOOL, manufactured by Arthro-Medic, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K893598 · Arthro-Medic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
154d
Days
Class 1
Risk

K893598 is an FDA 510(k) clearance for the HYDRAULIC FOOT OPERATED STOOL. Classified as Chair, Surgical, Ac-powered (product code GBB), Class I - General Controls.

Submitted by Arthro-Medic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 10, 1989 after a review of 154 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - 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 Arthro-Medic, Inc. devices

FDA 510(k) Submission Details - K893598

510(k) Number K893598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date October 10, 1989
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

GBB Device Classification - Class 1, General Controls

Product Code GBB Chair, Surgical, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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 - GBB Chair, Surgical, Ac-powered

Devices cleared under the same product code (GBB) and FDA review panel - the closest regulatory comparables to K893598.
TENET TIBIAL FRACTURE SUPPORT
K964102 · Tenet Medical Engineering · Dec 1996
LITHOTOMY CHAIR #415
K831385 · Midmark Corp. · Jun 1983
NAGASHIMA SN OPERATOR'S CHAIR
K822264 · Kelleher Corp. · Oct 1982
EXAMINATION & TREATMENT CHAIRS
K822251 · Kelleher Corp. · Aug 1982
NAGASHIMA SN AUTOMATIC TREATMENT CHAIR
K822013 · Kelleher Corp. · Jul 1982
STORZ #6500 POWER EXAMINATION CHAIR
K820636 · Storz Instrument Co. · Mar 1982