Cleared Traditional

PARKES HUMP GAUGE STRAIGHT 7 (18 CM) (K760850) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K760850 · V. Mueller O.V. Baxter Healthcare Corp. · General & Plastic Surgery device
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Nov 1976
Decision
19d
Days
Class 1
Risk

K760850 is an FDA 510(k) clearance for the PARKES HUMP GAUGE STRAIGHT 7 (18 CM). Classified as Gouge, Surgical, General & Plastic Surgery (product code GDH), Class I - General Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1976 after a review of 19 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1976
Decision Date November 03, 1976
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDH Gouge, 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 - GDH Gouge, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GDH) and FDA review panel - the closest regulatory comparables to K760850.
MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
K903419 · United States Surgical, A Division of Tyco Healthc · Aug 1990
MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
K900487 · United States Surgical, A Division of Tyco Healthc · Feb 1990
AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE
K874879 · United States Surgical, A Division of Tyco Healthc · Dec 1987