510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153358Substantially Equivalent

Standard Clamp

Standard Bariatrics, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153358 is the FDA 510(k) clearance record for Standard Clamp, a class I device, cleared for Standard Bariatrics on under FDA product code GDJ (Clamp, Surgical, General & Plastic Surgery). FDA records list 12 510(k) clearances for Standard Bariatrics, from to . As of , FDA records show no recalls naming K153358.

Clearance record

Decision date
Received
(164 days to decision)
Product code
GDJ Clamp, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Standard Bariatrics 4362 Glendale Milford Rd., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GDJ

Trailing 12 months

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

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