Cleared Traditional

K992640 - SLIMLINE SURGICAL CLAMP

Also marketed or referenced as:
SLIMLINE JAW INSERTS

K992640 is an FDA 510(k) clearance for SLIMLINE SURGICAL CLAMP, manufactured by Minumys Surgical, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K992640 · Minumys Surgical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
33d
Days
Class 2
Risk

K992640 is an FDA 510(k) clearance for the SLIMLINE SURGICAL CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Minumys Surgical, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 8, 1999 after a review of 33 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 Minumys Surgical, Inc. devices

FDA 510(k) Submission Details - K992640

510(k) Number K992640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date September 08, 1999
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
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: 125d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K992640.
ENGAGE JAW INSERTS
K992980 · Novare Surgical Systems, Inc. · Jun 2000
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · Pilling Weck Surgical · Mar 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · Cordis Neurovascular, Inc. · Aug 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · Allegiance Healthcare Corp. · May 1999
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
K982365 · Geister Medizin Technik GmbH · Apr 1999