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
K902349Substantially Equivalent

Surgitek Intra-Span Intraoperative Tissue Expander

Surgitek, Paso Robles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902349 is the FDA 510(k) clearance record for SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER, a class I device, cleared for Surgitek on under FDA product code FZW (Expander, Surgical, Skin Graft). FDA records list 29 510(k) clearances for Surgitek, from to . As of , FDA records show no recalls naming K902349.

Clearance record

Decision date
Received
(103 days to decision)
Product code
FZW Expander, Surgical, Skin Graft
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Surgitek 3003 Rollie Gates Dr., Paso Robles CA
Third party review
No

Clearances, product code FZW

Trailing 12 months

FDA records hold no clearances under product code FZW in the trailing twelve months.

FDA records show no clearances under product code FZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260