Cleared Traditional

K993135 - IMPLANTABLE CLIP FOR GENERAL SURGERY

K993135 is an FDA 510(k) clearance for IMPLANTABLE CLIP FOR GENERAL SURGERY, manufactured by Applied Medical Resources. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K993135 · Applied Medical Resources · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
72d
Days
Class 2
Risk

K993135 is an FDA 510(k) clearance for the IMPLANTABLE CLIP FOR GENERAL SURGERY. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on December 1, 1999 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K993135

510(k) Number K993135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date December 01, 1999
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 104
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K993135.
BIOPSY SITE MARKER
K011402 · Senorx, Inc. · Jul 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · Applied Medical Resources Corp. · May 2001
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · United States Surgical, A Division of Tyco Healthc · Jul 2000
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · United States Surgical, A Division of Tyco Healthc · Jan 1999
IMPLANTABLE CLIP
K970793 · United States Surgical, A Division of Tyco Healthc · Jul 1997
AUTO SUTURE* ILM** KIT
K971201 · United States Surgical, A Division of Tyco Healthc · Jun 1997