510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K172140Substantially Equivalent

NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)

Polynovo Biomaterials Pty Ltd, Port Melbourne, AU / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172140 is the FDA 510(k) clearance record for NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm), cleared for Polynovo Biomaterials Pty, Ltd. on under FDA product code QSZ (Absorbable Synthetic Wound Dressing). FDA's definition for product code QSZ reads: "Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application". FDA records list 6 510(k) clearances for Polynovo Biomaterials Pty, Ltd., from to . As of , FDA records show no recalls naming K172140.

Clearance record

Decision date
Received
(25 days to decision)
Product code
QSZ Absorbable Synthetic Wound Dressing
Device class
Unclassified
Review panel
Unknown
Applicant
Polynovo Biomaterials Pty, Ltd. Unit 2, 320 Lorimer St., Port Melbourne, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSZ

Trailing 12 months
3 clearances under product code QSZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260