510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812691Substantially Equivalent

Silicone Implants

Sutter Biomedical, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812691 is the FDA 510(k) clearance record for SILICONE IMPLANTS, a class I device, cleared for Sutter Biomedical, Inc. on under FDA product code MDM (Instrument, Manual, Surgical, General Use). FDA records list 11 510(k) clearances for Sutter Biomedical, Inc., from to . As of , FDA records show no recalls naming K812691.

Clearance record

Decision date
Received
(55 days to decision)
Product code
MDM Instrument, Manual, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sutter Biomedical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code MDM

Trailing 12 months

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

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