Cleared Traditional

K810888 - BOUNDARY TUBING HOLDERS

K810888 is an FDA 510(k) clearance for BOUNDARY TUBING HOLDERS, manufactured by The Buckeye Cellulose Corp.. The device is a Class 1 General & Plastic Surgery device with product code FZX cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K810888 · The Buckeye Cellulose Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
21d
Days
Class 1
Risk

K810888 is an FDA 510(k) clearance for the BOUNDARY TUBING HOLDERS. Classified as Guide, Surgical, Instrument (product code FZX), Class I - General Controls.

Submitted by The Buckeye Cellulose Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 21 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 The Buckeye Cellulose Corp. devices

FDA 510(k) Submission Details - K810888

510(k) Number K810888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1981
Decision Date April 23, 1981
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

FZX Device Classification - Class 1, General Controls

Product Code FZX Guide, Surgical, Instrument
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 - FZX Guide, Surgical, Instrument

All 12
Devices cleared under the same product code (FZX) and FDA review panel - the closest regulatory comparables to K810888.
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350 · Acufex Microsurgical, Inc. · Mar 1984
GRAF MENISCAL SUTURE SET
K830720 · Acufex Microsurgical, Inc. · Jun 1983
DISPOSABLE NEEDLE HOLDERS
K821618 · Medcare Products · Jun 1982
GABBAY-FRATER SUTURE GUIDE
K802093 · Howmedica Corp. · Sep 1980
FEEDING TUBE PLACEMENT STYLET
K792468 · Biosearch Medical Products, Inc. · Dec 1979
ENTERIC TUBE GUIDE
K790872 · Biosearch Medical Products, Inc. · May 1979