Cleared Traditional

K782006 - MEDGENERAL SINGLE-USE BULLDOG

K782006 is the FDA 510(k) clearance for MEDGENERAL SINGLE-USE BULLDOG by Med General. It is a Class 1 General & Plastic Surgery device (product code GDJ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K782006 · Med General · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
14d
Days
Class 1
Risk

K782006 is an FDA 510(k) clearance for the MEDGENERAL SINGLE-USE BULLDOG. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Med General (Mchenry, US). The FDA issued a Cleared decision on December 15, 1978 after a review of 14 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 Med General devices

Submission Details

510(k) Number K782006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1978
Decision Date December 15, 1978
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDJ Clamp, Surgical, General & Plastic Surgery
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 - GDJ Clamp, Surgical, General & Plastic Surgery

All 12
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K782006.
VESSEL OCCLUDER
K800074 · Cordis Corp. · Jan 1980
CONPHAR UMBILICAL CORD CLAMP
K791800 · Conphar, Inc. · Sep 1979
CONPHAR TUBE CLAMPS
K791802 · Conphar, Inc. · Sep 1979
BRACHIAL-LARGE VESSEL APPROXIMATOR
K780286 · Edward Weck, Inc. · Feb 1978
BRACHEAL-LARGE VESSEL CLIP
K780288 · Edward Weck, Inc. · Feb 1978
ULNAR-RADIAL CLIP
K780290 · Edward Weck, Inc. · Feb 1978