510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091135Substantially Equivalent

Rutter Supra Stomal Stents

Boston Medical Products, Inc., Westborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K091135 is the FDA 510(k) clearance record for RUTTER SUPRA STOMAL STENTS, a class II device, cleared for Boston Medical Products, Inc. on under FDA product code FWN (Prosthesis, Larynx (Stents And Keels)). FDA records list 33 510(k) clearances for Boston Medical Products, Inc., from to . As of , FDA records show no recalls naming K091135.

Clearance record

Decision date
Received
(147 days to decision)
Product code
FWN Prosthesis, Larynx (Stents And Keels)
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Boston Medical Products, Inc. 117 Flanders Rd., Westborough MA
510(k) summary
Statement
Third party review
No

Clearances, product code FWN

Trailing 12 months

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

FDA records show no clearances under product code FWN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FWN, 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