Cleared Traditional

K770534 - THERAPEUTIC APPARATUS

K770534 is the FDA 510(k) clearance for THERAPEUTIC APPARATUS by Well Being Ent.. It is a Class 2 Gastroenterology & Urology device (product code KDH) cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K770534 · Well Being Ent. · Gastroenterology & Urology device
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Apr 1978
Decision
396d
Days
Class 2
Risk

K770534 is an FDA 510(k) clearance for the THERAPEUTIC APPARATUS, DIERKER TYPE. Classified as Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (product code KDH), Class II - Special Controls.

Submitted by Well Being Ent. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1978 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Well Being Ent. devices

Submission Details

510(k) Number K770534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1977
Decision Date April 21, 1978
Days to Decision 396 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 130d · This submission: 396d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration

Devices cleared under the same product code (KDH) and FDA review panel - the closest regulatory comparables to K770534.
FLUSHING IRRIGATION SET
K923497 · Orion Life Systems, Inc. · Mar 1994
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp · Mar 1990
TUBING, AXIOM SILICONE PENROSE
K781749 · Axiom Medical, Inc. · Dec 1978
ARGYLE RAPID GASTRIC LAVAGE KIT
K770248 · Sherwood Medical Industries · Mar 1977
IRRIGATION CATHETER
K760556 · Sherwood Medical Industries · Feb 1977