510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982065Substantially Equivalent

Sterile Silicone External Wound Cover

Specialty Surgical Products, Inc., Hamilton MT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982065 is the FDA 510(k) clearance record for STERILE SILICONE EXTERNAL WOUND COVER, a class II device, cleared for Specialty Surgical Products, Inc. on under FDA product code MIB (Elastomer, Silicone Block). FDA records list 13 510(k) clearances for Specialty Surgical Products, Inc., from to . As of , FDA records show no recalls naming K982065.

Clearance record

Decision date
Received
(61 days to decision)
Product code
MIB Elastomer, Silicone Block
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Specialty Surgical Products, Inc. 302 N. First St., Hamilton MT
510(k) summary
Statement
Third party review
No

Clearances, product code MIB

Trailing 12 months

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

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