Cleared Traditional

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

K905068 · Pioneering Technologies, Inc. · General & Plastic Surgery device
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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.

View all Pioneering Technologies, Inc. devices

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 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K905068.
SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE
K935942 · Mcneil Healthcare, Inc. · Jan 1994
DYNAREX GAUZE SPONGE OR PADS
K933308 · Dynarex Corp. · Dec 1993
NU-BREDE PACKING AND DEBRIDEMENT SPONGE
K921983 · Johnson & Johnson Medical, Inc. · Sep 1992
SERENE WRAP
K895865 · Byron Medical · Dec 1989
LAP SPONGE
K896801 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1989