Cleared Traditional

WETTING AGENTS (K771843) - FDA 510(k) Clearance

K771843 · Gamma Enterprises, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1977
Decision
62d
Days
-
Risk

K771843 is an FDA 510(k) clearance for the WETTING AGENTS.

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. 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 Gamma Enterprises, Inc. devices

Submission Details

510(k) Number K771843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1977
Decision Date November 22, 1977
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -