510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K921993Substantially Equivalent

Els Automatic Tubing Clamp System

Rocky Mountain Research, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921993 is the FDA 510(k) clearance record for ELS AUTOMATIC TUBING CLAMP SYSTEM, a class II device, cleared for Rocky Mountain Research, Inc. on under FDA product code FIG (Clamp, Tubing, Blood, Automatic). FDA records list 5 510(k) clearances for Rocky Mountain Research, Inc., from to . As of , FDA records show no recalls naming K921993.

Clearance record

Decision date
Received
(617 days to decision)
Product code
FIG Clamp, Tubing, Blood, Automatic
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rocky Mountain Research, Inc. 2715 E. 3300 S., Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code FIG

Trailing 12 months

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

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