510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984448Substantially Equivalent

Bircoll Balloon Dissector

Wells Johnson Co., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984448 is the FDA 510(k) clearance record for BIRCOLL BALLOON DISSECTOR, a class I device, cleared for Wells Johnson Co. on under FDA product code FZW (Expander, Surgical, Skin Graft). FDA records list 15 510(k) clearances for Wells Johnson Co., from to . As of , FDA records show no recalls naming K984448.

Clearance record

Decision date
Received
(45 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
Wells Johnson Co. 8000 S. Kolb Rd., Tucson AZ
510(k) summary
Statement
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