Cleared Traditional

K970817 - MICROMARK CLIP

K970817 is an FDA 510(k) clearance for MICROMARK CLIP, manufactured by Biopsys Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K970817 · Biopsys Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
189d
Days
Class 2
Risk

K970817 is an FDA 510(k) clearance for the MICROMARK CLIP. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Biopsys Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 11, 1997 after a review of 189 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biopsys Medical, Inc. devices

FDA 510(k) Submission Details - K970817

510(k) Number K970817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1997
Decision Date September 11, 1997
Days to Decision 189 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 160
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K970817.
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K991030 · Ethicon Endo-Surgery, Inc. · May 1999
AUTO SUTURE SITE MARKER CLIP
K983400 · United States Surgical, A Division of Tyco Healthc · Feb 1999
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
K983536 · Ethicon Endo-Surgery, Inc. · Dec 1998
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · United States Surgical, A Division of Tyco Healthc · Oct 1995
SURGICAL STAPLE
K942606 · United States Surgical, A Division of Tyco Healthc · Aug 1994
STRYKER STAPLER SYSTEM
K931103 · Stryker Endoscopy · Oct 1993