Cleared Traditional

K973299 - PIN CARE KIT

K973299 · Brown Medical Industries · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
85d
Days
-
Risk

K973299 is an FDA 510(k) clearance for the PIN CARE KIT. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Brown Medical Industries (Spirit Lake, US). The FDA issued a Cleared decision on November 26, 1997 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brown Medical Industries devices

FDA 510(k) Submission Details - K973299

510(k) Number K973299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date November 26, 1997
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 132
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K973299.
DYNAREX TRACHEOSTOMY SPONGE
K983348 · Dynarex Corp. · Dec 1998
KENDALL CURITY IODOFORM PACKING STRIP
K973763 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
INVOTEC CLEAN PAD
K973580 · Invotec International, Inc. · Dec 1997
OPPORTUNITY INCISION AND DRAINAGE TRAY
K971088 · Opportunity, Inc. · Sep 1997
OPPORTUNITY SUTURE REMOVAL KIT
K971095 · Opportunity, Inc. · Sep 1997
RAND SURGICAL SPONGE
K971178 · Trans Aire · Jun 1997