Cleared Traditional

K961100 - MICRO ANASTOMOSIS CLAMP

K961100 is an FDA 510(k) clearance for MICRO ANASTOMOSIS CLAMP, manufactured by R.S.P. Medical Management, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K961100 · R.S.P. Medical Management, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
92d
Days
Class 2
Risk

K961100 is an FDA 510(k) clearance for the MICRO ANASTOMOSIS CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by R.S.P. Medical Management, Inc. (Irvine, US). The FDA issued a Cleared decision on June 19, 1996 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all R.S.P. Medical Management, Inc. devices

FDA 510(k) Submission Details - K961100

510(k) Number K961100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date June 19, 1996
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 151
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K961100.
D. DEVICE II
K955742 · Yousef Daneshvar · Aug 1996
TAPE & BANDAGE, ADHESIVE
K955270 · Robert R. Stevens · Aug 1996
DANESHVAR'S DEVICE (MODIFICATION)
K961461 · Y. Daneshvar · Jun 1996
HEARTPORT ENDOAORTIC CLAMP
K955132 · Heartport, Inc. · Jun 1996
FEMOSTOP, FEMOSTOP PUMP
K954669 · Radi Medical Systems AB · Oct 1995
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995