Cleared Traditional

K942234 - VISITEC PRECISE-POINT

K942234 is an FDA 510(k) clearance for VISITEC PRECISE-POINT, manufactured by Visitec Co.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K942234 · Visitec Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
64d
Days
Class 2
Risk

K942234 is an FDA 510(k) clearance for the VISITEC PRECISE-POINT. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - 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 Visitec Co. devices

FDA 510(k) Submission Details - K942234

510(k) Number K942234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date July 12, 1994
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 18
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K942234.
SOFSILK SUTURE
K980124 · United States Surgical, A Division of Tyco Healthc · Mar 1998
SOFSILK
K964581 · United States Surgical, A Division of Tyco Healthc · Jan 1997
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K930739 · Deknatel, Inc. · Jul 1994
NONABSORBABLE SILK SURGICAL SUTURE
K904478 · United States Surgical, A Division of Tyco Healthc · Nov 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
K904891 · United States Surgical, A Division of Tyco Healthc · Nov 1990
AIRWAY PRESSURE MONITOR
K761199 · Draeger Medical, Inc. · Feb 1977