Cleared Traditional

K905068 - PTI INTRA-ART (TM) PICK-UP WICKS

K905068 · Pioneering Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
417d
Days
-
Risk

K905068 is an FDA 510(k) clearance for the PTI INTRA-ART (TM) PICK-UP WICKS. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Pioneering Technologies, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on December 31, 1991 after a review of 417 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K905068

510(k) Number K905068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1990
Decision Date December 31, 1991
Days to Decision 417 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 115d · This submission: 417d
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 270
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K905068.
NU-BREDE PACKING AND DEBRIDEMENT SPONGE
K921983 · Johnson & Johnson Medical, Inc. · Sep 1992
STERILE AND NON-STERILE GAUZE SPONGES
K922055 · Team Mfg., Inc. · Aug 1992
INTESTINAL SPONGES
K923041 · Surgic Aid, Inc. · Aug 1992
EYE PAD
K912955 · Cal West Trading Co. · Sep 1991
GAUZE SPONGES ABSORBENT GAUZE ROLLS
K910623 · Liaoning-Usa Corp. · Apr 1991
GAUZE SPONGES, INTERNAL AND EXTERNAL
K905136 · American Healthcare Corp. · Mar 1991
K905068 · PTI INTRA-ART (TM) PICK-UP WICKS
Download PDF Pioneering Technologi…