Cleared Traditional

K940765 - ISOLYSER

K940765 · Thantex Specialties, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
304d
Days
-
Risk

K940765 is an FDA 510(k) clearance for the ISOLYSER. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Thantex Specialties, Inc. (Norcross, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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. Elevated predicate reliance profile. 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 Thantex Specialties, Inc. devices

FDA 510(k) Submission Details - K940765

510(k) Number K940765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date December 19, 1994
Days to Decision 304 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 115d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 84
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K940765.
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · Smith & Nephew United, Inc. · Jul 1996
LESINSKI SURGICAL EAR DRESSING
K950906 · Microtek Medical, Inc. · Jun 1995
OREX
K940716 · Thantex Specialties, Inc. · Dec 1994
STERILE GAUZE PRODUCT LINE
K941455 · Cush Medical Products · May 1994
ISOLYER (4X4, 12 PLY)
K940754 · Thantex Specialties, Inc. · May 1994
TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE
K940574 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1994