Cleared Traditional

K861924 - MICRO ANASTOMOSIS CLAMP

K861924 is the FDA 510(k) clearance for MICRO ANASTOMOSIS CLAMP by Pilling Co.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K861924 · Pilling Co. · Cardiovascular device
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Jun 1986
Decision
18d
Days
Class 2
Risk

K861924 is an FDA 510(k) clearance for the MICRO ANASTOMOSIS CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on June 6, 1986 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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 Pilling Co. devices

Submission Details

510(k) Number K861924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1986
Decision Date June 06, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 46
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K861924.
OCCLUSION CLAMP** DEVICE
K964251 · United States Surgical, A Division of Tyco Healthc · May 1997
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988
FOGARTY 6MM SOFTJAW CLIP
K832554 · American Edwards Laboratories · Sep 1983
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K810162 · American Edwards Laboratories · Feb 1981
LOUISVILLE CLAMP PRODUCT #65-172
K770503 · Edward Weck, Inc. · Mar 1977