Cleared Traditional

K923381 - SOFT TISSUE EXPANDER

K923381 is an FDA 510(k) clearance for SOFT TISSUE EXPANDER, manufactured by Acufex Microsurgical, Inc.. The device is a Class 1 Orthopedic device with product code HWQ cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K923381 · Acufex Microsurgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
300d
Days
Class 1
Risk

K923381 is an FDA 510(k) clearance for the SOFT TISSUE EXPANDER. Classified as Passer (product code HWQ), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on May 5, 1993 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K923381

510(k) Number K923381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1992
Decision Date May 05, 1993
Days to Decision 300 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 122d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

HWQ Device Classification - Class 1, General Controls

Product Code HWQ Passer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWQ Passer

Devices cleared under the same product code (HWQ) and FDA review panel - the closest regulatory comparables to K923381.
MITEK SUTURE RETROGRADER
K970360 · Mitek Products · Mar 1997
ACUFEX PASSING PINS AND SURGICAL WIRE
K920621 · Acufex Microsurgical, Inc. · May 1993
MENISCUS MENDER II LOOP
K885311 · Instrument Makar, Inc. · Feb 1989
VICO MICRO SURGICAL INSTRUMENTS
K843592 · Visitec Co. · Oct 1984
SILASTIC TENDON PASSER H.P.
K811679 · Dow Corning Corp. Healthcare Industries Materials · Jul 1981
ROTH-KENNEDY PASSER
K791960 · 3M Company · Oct 1979