510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K930514Substantially Equivalent

Surgic-Alert Monitor

Novatec Medical Products, Inc.--Glove Monitor, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930514 is the FDA 510(k) clearance record for SURGIC-ALERT MONITOR, cleared for Novatec Medical Products, Inc.--Glove Monitor on under FDA product code LDQ. FDA records list one 510(k) clearance for Novatec Medical Products, Inc.--Glove Monitor. As of , FDA records show no recalls naming K930514.

Clearance record

Decision date
Received
(199 days to decision)
Product code
LDQ
Review panel
General Hospital
Applicant
Novatec Medical Products, Inc.--Glove Monitor 305 Mayerling Dr., Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code LDQ

Trailing 12 months

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

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