Cleared Traditional

K840307 - CAT. 3 GASTROENTEROLOGY-UROLOGY DEV

K840307 is an FDA 510(k) clearance for CAT. 3 GASTROENTEROLOGY-UROLOGY DEV, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code HTD cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K840307 · Imm Enterprises , Ltd. · General & Plastic Surgery device
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Mar 1984
Decision
48d
Days
Class 1
Risk

K840307 is an FDA 510(k) clearance for the CAT. 3 GASTROENTEROLOGY-UROLOGY DEV. Classified as Forceps (product code HTD), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 48 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 Imm Enterprises , Ltd. devices

FDA 510(k) Submission Details - K840307

510(k) Number K840307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date March 12, 1984
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

HTD Device Classification - Class 1, General Controls

Product Code HTD Forceps
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 - HTD Forceps

All 58
Devices cleared under the same product code (HTD) and FDA review panel - the closest regulatory comparables to K840307.
CATEGORY 17-MICROBIOLOGY DEVICES
K840304 · Imm Enterprises , Ltd. · May 1984
CAT. 14-CLINICAL TOXIOLOGY DEVICES
K840318 · Imm Enterprises , Ltd. · Apr 1984
CATEGORY 2 GEN. HOSPITAL & PERSONAL USE
K840306 · Imm Enterprises , Ltd. · Mar 1984
CAT. 5-RADIOLOGY DEVICES
K840309 · Imm Enterprises , Ltd. · Mar 1984
CAT 11- GENERAL & PLASTIC SURGERY DEV
K840315 · Imm Enterprises , Ltd. · Mar 1984
CAT 12-ORTHOPEDIC & REHAB DEVICE
K840316 · Imm Enterprises , Ltd. · Mar 1984