Cleared Traditional

K922739 - HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHM...

K922739 is an FDA 510(k) clearance for HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHM..., manufactured by Hollister, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K922739 · Hollister, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
59d
Days
Class 1
Risk

K922739 is an FDA 510(k) clearance for the HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on August 6, 1992 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K922739

510(k) Number K922739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date August 06, 1992
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 33
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K922739.
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
K925748 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
TURKEL ABDOMINAL PARACENTESIS SYSTEM
K924702 · Symbiosis Corp. · Jan 1993
SIL-MED FLAT SUCTION DRAIN
K921424 · Sil-Med Corp. · Sep 1992
I/A HANDPIECE WITH REPLACEABLE TIPS
K910245 · Surgical Technologies, Inc. · Apr 1991
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614 · Baxter Healthcare Corp · Mar 1991
PVC ROUND WOUND DRAINS
K905422 · Axiom Medical, Inc. · Feb 1991