Cleared Traditional

K973763 - KENDALL CURITY IODOFORM PACKING STRIP

K973763 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
90d
Days
-
Risk

K973763 is an FDA 510(k) clearance for the KENDALL CURITY IODOFORM PACKING STRIP. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on December 31, 1997 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K973763

510(k) Number K973763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1997
Decision Date December 31, 1997
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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