510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950754Substantially Equivalent

Macro Suction Tube Model No 10061

Dlp, Inc., Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950754 is the FDA 510(k) clearance record for MACRO SUCTION TUBE MODEL NO 10061, a class I device, cleared for Dlp, Inc. on under FDA product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered). FDA records list 39 510(k) clearances for Dlp, Inc., from to . As of , FDA records show no recalls naming K950754.

Clearance record

Decision date
Received
(67 days to decision)
Product code
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Regulation
21 CFR 878.4680
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dlp, Inc. 620 Watson SW, Grand Rapids MI
510(k) summary
Statement
Third party review
No

Clearances, product code GCY

Trailing 12 months

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

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