Cleared Traditional

K801660 - PROXIMATE * PSD PURSE-STRING DEVICE

K801660 is the FDA 510(k) clearance for PROXIMATE * PSD PURSE-STRING DEVICE by Ethicon, Inc.. It is a Class 1 General & Plastic Surgery device (product code GDJ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K801660 · Ethicon, Inc. · General & Plastic Surgery device
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Aug 1980
Decision
23d
Days
Class 1
Risk

K801660 is an FDA 510(k) clearance for the PROXIMATE * PSD PURSE-STRING DEVICE. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 23 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 Ethicon, Inc. devices

Submission Details

510(k) Number K801660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1980
Decision Date August 13, 1980
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 14
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K801660.
TOURIQUET KIT WITH SNARE
K855144 · Dlp, Inc. · Feb 1986
BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420
K852724 · The Huxley Instrument Corp. · Jul 1985
17-900 TO 17-980 VARIOUS TOWEL CLAMPS
K851774 · Artiberia · Jun 1985
VESSEL OCCLUDER
K800074 · Cordis Corp. · Jan 1980
CONPHAR UMBILICAL CORD CLAMP
K791800 · Conphar, Inc. · Sep 1979
CONPHAR TUBE CLAMPS
K791802 · Conphar, Inc. · Sep 1979