510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K955270Substantially Equivalent

Tape & Bandage, Adhesive

Robert R. Stevens, Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955270 is the FDA 510(k) clearance record for TAPE & BANDAGE, ADHESIVE, a class II device, cleared for Robert R. Stevens on under FDA product code DXC (Clamp, Vascular). FDA records list 2 510(k) clearances for Robert R. Stevens, from to . As of , FDA records show no recalls naming K955270.

Clearance record

Decision date
Received
(267 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Robert R. Stevens 15720 Bull Run Rd. #377, Miami Lakes FL
510(k) summary
Summary
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260