510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944163Substantially Equivalent

Spectrum Disigns Pectoral Implant

Spectrum Designs, Inc., Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944163 is the FDA 510(k) clearance record for SPECTRUM DISIGNS PECTORAL IMPLANT, a class II device, cleared for Spectrum Designs, Inc. on under FDA product code MIC (Implant, Muscle, Pectoralis). FDA records list 18 510(k) clearances for Spectrum Designs, Inc., from to . As of , FDA records show no recalls naming K944163.

Clearance record

Decision date
Received
(73 days to decision)
Product code
MIC Implant, Muscle, Pectoralis
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Spectrum Designs, Inc. 5921-C Matthews St., Goleta CA
510(k) summary
Statement
Third party review
No

Clearances, product code MIC

Trailing 12 months

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

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